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| Name | Class |
|---|---|
| Framingham State University | OTHER |
| Baylor College of Medicine | OTHER |
| Nutrition Science Initiative | OTHER |
| New Balance Foundation |
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This study will evaluate the effects of dietary composition on energy expenditure and chronic disease risk factors, while also exploring physiological mechanisms underlying these effects.
Many overweight and obese people can lose weight for a few months, but most have difficulty maintaining weight loss over the long term. One explanation for the poor long-term outcome of weight-loss diets relates to behavior, in that motivation to adhere to restrictive regimens typically diminishes with time. An alternative explanation is that weight loss elicits biological adaptations - specifically a decline in energy expenditure and an increase in hunger - that promote weight regain. The purpose of this study is to evaluate the effects of dietary composition on energy expenditure and risk for chronic diseases, while also exploring physiological mechanisms underlying these effects. The study will be performed in collaboration with Framingham State University, providing a novel and feasible method for feeding subjects in dining halls and monitoring compliance.
Following 12±2% weight loss on a standard run-in diet, 150 adults (aged 18 to 65 years) will be randomly assigned to one of three weight-loss maintenance diets controlled for protein content (20% of energy) and varying widely in dietary carbohydrate-to-fat ratio: Low-carbohydrate (20% of energy from carbohydrate, 60% fat), Moderate- carbohydrate (40% carbohydrate, 40% fat), High-carbohydrate (60% carbohydrate, 20% fat). During the weight-loss maintenance phase, energy intake will be adjusted to prevent changes in body weight. The primary outcome will be change in total energy expenditure (indirect calorimetry using stable isotopes) through 20 weeks. Secondary outcomes during weight maintenance will include resting energy expenditure (indirect calorimetry using respiratory gas exchange), physical activity (accelerometry), measures of insulin resistance and skeletal muscle work efficiency, components of the metabolic syndrome, and hormonal and metabolic measures that might inform an understanding of physiological mechanisms. We also will assess weight change during a 2-week ad libitum feeding phase, as an objective measure of dietary effects on hunger. The analytic framework for addressing study hypothesis will be repeated-measures analysis of variance, with adjustment for covariates (sex, race, ethnicity, age, anthropometrics, insulin sensitivity and secretion, obesity-related genes). We also will test each covariate for effect modification (covariate × diet interaction).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low carbohydrate diet | Experimental | Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein |
|
| Moderate carbohydrate diet | Experimental | Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein |
|
| High carbohydrate diet | Active Comparator | Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feeding study | Behavioral | Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes | Total energy expenditure (TEE), assessed by indirect calorimetry using stable isotopes Total calories burned: Participants each drank about a cup of water containing special tracers which are measurable when they pass out of the body through urine. They provided a urine sample before they drank the water and then about every other day for the next two (2) weeks. Change: average (midpoint of test phase, end of test phase) - start of trial | Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Measure | Description | Time Frame |
|---|---|---|
| Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange | Resting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange Calories burned while resting: Participants lied down with head and neck under a clear plastic "bubble," breathing room air. Gases in expired air were collected. Change: average (midpoint of test phase, end of test phase) - start of trial |
| Measure | Description | Time Frame |
|---|---|---|
| Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Effect modifier: Insulin level 30 minutes into an standard OGTT (Insulin-30) Outcome: Total Energy Expenditure Tertiles: Pre-weight-loss Insulin-30 (Low, Moderate, High) Change: average (midpoint of test phase, end of test phase) - start of trial | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gloria Klein, MS, RD | Boston Children's Hospital | Study Director |
| Cara B Ebbeling, PhD | Boston Children's Hospital | Principal Investigator |
| David S Ludwig, MD, PhD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Framingham State University | Framingham | Massachusetts | 01702 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30283914 | Background | Wong JM, Bielak L, Eddy RG, Stone L, Lakin PR, Sandman M, Devlin C, Seger-Shippee L, Wiroll D, Luoto PK, Klein GL, Ludwig DS, Ebbeling CB. An Academia-Industry Partnership for Planning and Executing a Community-Based Feeding Study. Curr Dev Nutr. 2018 Jul 5;2(9):nzy060. doi: 10.1093/cdn/nzy060. eCollection 2018 Sep. | |
| 29233719 |
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We enrolled 234 participants for the run-in phase. Of these, 164 participants achieved at least 10% weight loss and were randomly assigned to one of three diets for the test phase (low-carbohydrate diet, n=57; moderate-carbohydrate diet, n=53; or high-carbohydrate diet, n=54).
We recruited participants by posting flyers, newspaper advertisements, and Internet announcements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Carbohydrate Diet | Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum |
| FG001 | Moderate Carbohydrate Diet | Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum |
| FG002 | High Carbohydrate Diet | Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Carbohydrate Diet | Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum |
| BG001 | Moderate Carbohydrate Diet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Energy Expenditure, Assessed by Indirect Calorimetry Using Stable Isotopes | Total energy expenditure (TEE), assessed by indirect calorimetry using stable isotopes Total calories burned: Participants each drank about a cup of water containing special tracers which are measurable when they pass out of the body through urine. They provided a urine sample before they drank the water and then about every other day for the next two (2) weeks. Change: average (midpoint of test phase, end of test phase) - start of trial | Intention-to-treat analysis | Posted | Mean | 95% Confidence Interval | kcal/d | Start of Trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
|
Adverse event data were collected throughout the run-in diet (~12 weeks) and the test diet (20 weeks) periods of the study, a total of ~32 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-in Phase | Pre-randomization: During the run-in phase, energy intake was restricted to promote 12% (within 2%) weight loss over 9-10 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laparoscopic cholecystectomy | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
The study has three main limitations: potential measurement error, non-compliance, and generalizability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cara Ebbeling, PhD, Co-Director, New Balance Foundation Obesity Prevention Center | Boston Children's Hospital | 617-919-3457 | Cara.Ebbeling@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 14, 2017 | Jul 24, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2017 | Sep 12, 2017 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| OTHER |
| Many Voices Foundation | OTHER |
| Blue Cross Blue Shield | OTHER |
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| Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Physical Activity, Assessed by Accelerometry | Actigraph Accelerometer Change: average (midpoint of test phase, end of test phase) - start of trial An Actigraph Accelerometer measures movement, similar to a pedometer. Data are reported as counts (divided by 1,000) per day. Each participant wore the the accelerometer on the right hip for 7 days at each time point. | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Skeletal Muscle Work Efficiency | Efficiency is expressed as percentage ratio of power generated during cycle ergometry (with conversion of Watts to kcal/min using a factor of 0.01433) to energy expenditure above resting. Change: end of test phase - start of trial. | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Leptin (Start of Trial) | Leptin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 6) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial | Start of trial (time of randomization, post-weight loss) |
| Leptin (% Change) | Leptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial | Change through 20 weeks' weight loss maintenance |
| Ghrelin (Start of Trial) | Ghrelin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 8) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial | Start of trial (time of randomization, post-weight loss) |
| Ghrelin (% Change) | Ghrelin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial | Change through 20 weeks' weight loss maintenance |
| 1,5-Anhydroglucitol | Biomeasure of carbohydrate intake Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Glycemic Control, Assessed by HgA1c | Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial. | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Triglycerides | Triglyceride levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Body Composition (DXA) | Body fat, presented as a % of total mass Participants each had a special scan (x-ray) to measure their amount of body fat. The special x-ray is called "dual-energy x-ray absorptiometry" (DXA). They were asked to lie still on a table for x-ray pictures. Change: end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Glucose | Glucose level, fasting blood draw Change: end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Change in Lipoprotein Particle Subfraction Distribution | Lipoprotein insulin resistance (LPIR) score was calculated from triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (large/very large TRL-P, large HDL-P, small LDL-P). LPIR score is quantified on a scale of 0-100. Higher scores indicate worse outcome. Change: end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Total Cholesterol | Change: end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| HDL-Cholesterol | High-density lipoprotein cholesterol Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial. | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Non-HDL-Cholesterol | Calculated by subtracting HDL-cholesterol from total cholesterol. Change: end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| LDL-Cholesterol | Low-density-lipoprotein cholesterol Change: end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Adiponectin (Start of Trial) | Total and high molecular weight adiponectin Adiponectin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 20) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) |
| Adiponectin (% Change) | Adiponeptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial | Change through 20 weeks' weight loss maintenance |
| C-reactive Protein (Start of Trial) | C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 22) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) |
| C-reactive Protein (% Change) | C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial | Change through 20 weeks' weight loss maintenance |
| IL-6 (Start of Trial) | Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 24) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) |
| IL-6 (% Change) | Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial | Change through 20 weeks' weight loss maintenance |
| Blood Pressure | Systolic and diastolic blood pressure Change: end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Plasminogen Activator Inhibitor-1 (Start of Trial) | Plasminogen activator inhibitor-1 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 27) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) |
| Plasminogen Activator Inhibitor-1 (% Change) | Plasminogen activator inhibitor-1 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial | Change through 20 weeks' weight loss maintenance |
| Fibrinogen | Change: end of test phase - start of trial | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | Insulin level 30 minutes after consuming 75 grams of glucose | Start of trial (time of randomization, post-weight loss) |
| Thyroxine (T4) | thyroid function test | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Free T4 | free thyroxine, thyroid function test | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Thyroid Stimulating Hormone | Produced by the pituitary gland in the brain. Tells the thyroid gland to make thyroid hormones. | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Reverse T3 | thyroid function test, inactive form of triiodothyronine (T3) Lifespan Bio kit was used for analysis. The range of this kit is 250 to 5000 pg/mL, which varies from other commercially available kits (about 10-fold greater values). | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Urinary Cortisol Excretion | cortisol (stress hormone) excreted in the urine over a 24-hour period | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Urinary Catecholamine - Adrenaline | catecholamine excreted in the urine over 24 hours, also known as epinephrine | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Urinary Catecholamine - Dopamine | catecholamine excreted in the urine over 24 hours | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Urinary Catecholamine - Noradrenaline | catecholamine excreted in the urine over 24 hours, also known as norepinephrine | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Insulin Sensitivity (Hepatic), Assessed by Frequently-sampled Oral Glucose Tolerance Test | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Insulin Sensitivity (Systemic), Assessed by Frequently-sampled Oral Glucose Tolerance Test | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Non-esterified Fatty Acids | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Serum Ketones/Ketoacids | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Lactate | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Metabolic Fuel Concentration in Serum (Glucose, Nonesterified Fatty Acids, Ketones/Ketoacids, Lactate) | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Insulin-like Growth Factor 1 (IGF-1) | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| IGF Binding Proteins | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Testosterone | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Estradiol | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Luteinizing Hormone | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Follicle Stimulating Hormone | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Body Weight Change During ad Libitum Feeding | Ad libitum feeding period (weeks 21 and 22 following randomization) |
| Gut Microbiome Profile | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Serum Metabolomics Profile | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Change in Cognitive Function Related to Memory | California Verbal Learning Test - Second Edition [CVLT-II] and Digit Span Test | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Change in Cognitive Function Related to Processing Speed and Executive Function | Trail Making Test Parts A and B [TMT-A, TMT-B] | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Change in Self-reported Sleep Quality | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Change in Self-reported Depression Measure | Beck Depression Inventory-II [BDI-II] | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Change in Self-reported Mood/Anxiety | Mood and Anxiety Symptom Questionnaire [MASQ] | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Change in Self-reported Food Addiction Score | Yale Food Addiction Scale [YFAS] | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Change in Self-reported Emotional Eating Score | Emotional Eating Scale [EES] | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Change in Self-reported Binge Eating Score | Binge Eating Scale [BES] | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Effect Modification by Insulin Resistance of Metabolic Responses to Diet | Start of (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Effect Modification by Amylase Gene Copy Number | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
| Ebbeling CB, Klein GL, Luoto PK, Wong JMW, Bielak L, Eddy RG, Steltz SK, Devlin C, Sandman M, Hron B, Shimy K, Heymsfield SB, Wolfe RR, Wong WW, Feldman HA, Ludwig DS. A randomized study of dietary composition during weight-loss maintenance: Rationale, study design, intervention, and assessment. Contemp Clin Trials. 2018 Feb;65:76-86. doi: 10.1016/j.cct.2017.12.004. Epub 2017 Dec 9. |
| 32435054 | Background | Ludwig DS, Greco KF, Ma C, Ebbeling CB. Testing the carbohydrate-insulin model of obesity in a 5-month feeding study: the perils of post-hoc participant exclusions. Eur J Clin Nutr. 2020 Jul;74(7):1109-1112. doi: 10.1038/s41430-020-0658-8. Epub 2020 May 20. |
| 30429127 | Result | Ebbeling CB, Feldman HA, Klein GL, Wong JMW, Bielak L, Steltz SK, Luoto PK, Wolfe RR, Wong WW, Ludwig DS. Effects of a low carbohydrate diet on energy expenditure during weight loss maintenance: randomized trial. BMJ. 2018 Nov 14;363:k4583. doi: 10.1136/bmj.k4583. |
| 32470981 | Result | Ebbeling CB, Bielak L, Lakin PR, Klein GL, Wong JMW, Luoto PK, Wong WW, Ludwig DS. Energy Requirement Is Higher During Weight-Loss Maintenance in Adults Consuming a Low- Compared with High-Carbohydrate Diet. J Nutr. 2020 Aug 1;150(8):2009-2015. doi: 10.1093/jn/nxaa150. |
| 41547934 | Derived | Angelidi AM, Bartell E, Huang Y, Zeleznik OA, Estanyol-Torres N, Mi MY, Bhupathiraju SN, Kelly RS, Wittenbecher C, Lasky-Su J, Clish CB, Ludwig DS, Ebbeling CB, Hirschhorn JN. Weight-independent effects of dietary carbohydrate-to-fat ratio on metabolomic profiles: secondary outcomes of a 5-month randomized controlled feeding trial. Nat Commun. 2026 Jan 17;17(1):1662. doi: 10.1038/s41467-026-68353-z. |
| 34587231 | Derived | Wong JMW, Yu S, Ma C, Mehta T, Dickinson SL, Allison DB, Heymsfield SB, Ebbeling CB, Ludwig DS. Stimulated Insulin Secretion Predicts Changes in Body Composition Following Weight Loss in Adults with High BMI. J Nutr. 2022 Mar 3;152(3):655-662. doi: 10.1093/jn/nxab315. |
| 34582545 | Derived | Ebbeling CB, Knapp A, Johnson A, Wong JMW, Greco KF, Ma C, Mora S, Ludwig DS. Effects of a low-carbohydrate diet on insulin-resistant dyslipoproteinemia-a randomized controlled feeding trial. Am J Clin Nutr. 2022 Jan 11;115(1):154-162. doi: 10.1093/ajcn/nqab287. |
Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum |
| BG002 | High Carbohydrate Diet | Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | pre-weight loss, beginning of run-in phase | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total Energy Expenditure | pre-weight loss, beginning of run-in phase | Mean | Standard Deviation | kcal/d |
|
| OG001 | Moderate Carbohydrate Diet | Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum |
| OG002 | High Carbohydrate Diet | Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein Feeding study: Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum |
|
|
| Secondary | Resting Energy Expenditure, Assessed by Indirect Calorimetry Using Respiratory Gas Exchange | Resting energy expenditure, assessed by indirect calorimetry using respiratory gas exchange Calories burned while resting: Participants lied down with head and neck under a clear plastic "bubble," breathing room air. Gases in expired air were collected. Change: average (midpoint of test phase, end of test phase) - start of trial | Intention-to-treat analysis | Posted | Mean | 95% Confidence Interval | kcal/d | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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|
|
| Secondary | Physical Activity, Assessed by Accelerometry | Actigraph Accelerometer Change: average (midpoint of test phase, end of test phase) - start of trial An Actigraph Accelerometer measures movement, similar to a pedometer. Data are reported as counts (divided by 1,000) per day. Each participant wore the the accelerometer on the right hip for 7 days at each time point. | Intention-to-treat analysis | Posted | Mean | 95% Confidence Interval | counts/d | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Skeletal Muscle Work Efficiency | Efficiency is expressed as percentage ratio of power generated during cycle ergometry (with conversion of Watts to kcal/min using a factor of 0.01433) to energy expenditure above resting. Change: end of test phase - start of trial. | Posted | Mean | 95% Confidence Interval | % power generated to energy expended | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Leptin (Start of Trial) | Leptin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 6) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial | Intention-to-treat analysis | Posted | Mean | 95% Confidence Interval | ng/mL | Start of trial (time of randomization, post-weight loss) |
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| Secondary | Leptin (% Change) | Leptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial | Intention-to-treat analysis | Posted | Mean | 95% Confidence Interval | % change | Change through 20 weeks' weight loss maintenance |
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| Secondary | Ghrelin (Start of Trial) | Ghrelin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 8) are expressed in percentage units (100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial | Intention-to-treat analysis | Posted | Mean | 95% Confidence Interval | pg/mL | Start of trial (time of randomization, post-weight loss) |
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| Secondary | Ghrelin (% Change) | Ghrelin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): average (midpoint of test phase, end of test phase) - start of trial | Intention-to-treat analysis | Posted | Mean | 95% Confidence Interval | % change | Change through 20 weeks' weight loss maintenance |
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| Secondary | 1,5-Anhydroglucitol | Biomeasure of carbohydrate intake Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial | Posted | Mean | 95% Confidence Interval | ug/mL | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Glycemic Control, Assessed by HgA1c | Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial. | Posted | Mean | 95% Confidence Interval | % hemoglobin with glucose bound | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Triglycerides | Triglyceride levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units Change, 10 weeks: midpoint of test phase - start of trial Change, 20 weeks: end of test phase - start of trial | Posted | Mean | 95% Confidence Interval | md/dL | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Body Composition (DXA) | Body fat, presented as a % of total mass Participants each had a special scan (x-ray) to measure their amount of body fat. The special x-ray is called "dual-energy x-ray absorptiometry" (DXA). They were asked to lie still on a table for x-ray pictures. Change: end of test phase - start of trial | Intention-to-treat analysis | Posted | Mean | 95% Confidence Interval | % of total body mass | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Glucose | Glucose level, fasting blood draw Change: end of test phase - start of trial | Intention-to-treat analysis | Posted | Mean | 95% Confidence Interval | mg/dL | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Change in Lipoprotein Particle Subfraction Distribution | Lipoprotein insulin resistance (LPIR) score was calculated from triglyceride-rich, high-density, and low-density lipoprotein particle (TRL-P, HDL-P, LDL-P) sizes and subfraction concentrations (large/very large TRL-P, large HDL-P, small LDL-P). LPIR score is quantified on a scale of 0-100. Higher scores indicate worse outcome. Change: end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Mean | 95% Confidence Interval | score on a scale (0-100) | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Total Cholesterol | Change: end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Mean | 95% Confidence Interval | mg/dL | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | HDL-Cholesterol | High-density lipoprotein cholesterol Change, 10 weeks: midpoint of test phase - start of trial. Change, 20 weeks: end of test phase - start of trial. | Posted | Mean | 95% Confidence Interval | md/dL | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Non-HDL-Cholesterol | Calculated by subtracting HDL-cholesterol from total cholesterol. Change: end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Mean | 97.5% Confidence Interval | mg/dL | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | LDL-Cholesterol | Low-density-lipoprotein cholesterol Change: end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Mean | 95% Confidence Interval | mg/dL | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Adiponectin (Start of Trial) | Total and high molecular weight adiponectin Adiponectin levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 20) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Median | Inter-Quartile Range | ng/mL | Start of trial (time of randomization, post-weight loss) |
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| Secondary | Adiponectin (% Change) | Adiponeptin levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Mean | 95% Confidence Interval | % change | Change through 20 weeks' weight loss maintenance |
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| Secondary | C-reactive Protein (Start of Trial) | C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 22) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Median | Inter-Quartile Range | mg/L | Start of trial (time of randomization, post-weight loss) |
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| Secondary | C-reactive Protein (% Change) | C-reactive protein, marker of inflammation C-reactive protein levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Mean | 95% Confidence Interval | % change | Change through 20 weeks' weight loss maintenance |
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| Secondary | IL-6 (Start of Trial) | Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 24) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Median | Inter-Quartile Range | pg/mL | Start of trial (time of randomization, post-weight loss) |
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| Secondary | IL-6 (% Change) | Interleukin-6, marker of inflammation Interleukin-6 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Mean | 95% Confidence Interval | % change | Change through 20 weeks' weight loss maintenance |
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| Secondary | Blood Pressure | Systolic and diastolic blood pressure Change: end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Mean | 95% Confidence Interval | mmHg | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Plasminogen Activator Inhibitor-1 (Start of Trial) | Plasminogen activator inhibitor-1 levels were log transformed for analysis. For reporting, the adjusted means and 95% Confidence Intervals were retransformed to the original units (exp(mean log)±exp(mean log)×(exp(SE log)-1)). Changes (see Outcome 27) are expressed in percentage units (100%×(exp(change in log)-1)): end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Median | Inter-Quartile Range | ng/mL | Start of trial (time of randomization, post-weight loss) |
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| Secondary | Plasminogen Activator Inhibitor-1 (% Change) | Plasminogen activator inhibitor-1 levels were log transformed for analysis. Change (expressed in percentage units, 100%×(exp(change in log)-1)): end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Mean | 95% Confidence Interval | % change | Change through 20 weeks' weight loss maintenance |
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| Secondary | Fibrinogen | Change: end of test phase - start of trial | Retention rate was 90%, with 148 of 164 participants completing the study and 147 included in the analysis (after a priori exclusion of one participant who developed hypothyroidism). | Posted | Mean | 95% Confidence Interval | mg/dL | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Insulin Secretion Determined as Blood Insulin Concentration 30 Minutes After Oral Glucose (Start of Trial) | Insulin level 30 minutes after consuming 75 grams of glucose | Descriptive data, reflecting participant flow Pre-weight loss (N=162, minus 1 participant in the Moderate carbohydrate diet group for whom insulin-30 result is missing) Start of trial (N=162) End of test phase (N=148, minus 1 participant in the High carbohydrate diet group for whom insulin-30 result is missing) | Posted | Median | Inter-Quartile Range | mIU/L | Start of trial (time of randomization, post-weight loss) |
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| Secondary | Thyroxine (T4) | thyroid function test | Descriptive data, reflecting participant flow End of test phase (N=148, completers) | Posted | Median | Inter-Quartile Range | nmol/L | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Free T4 | free thyroxine, thyroid function test | Descriptive data, reflecting participant flow End of test phase (N=148, completers) | Posted | Median | Inter-Quartile Range | pmol/L | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Thyroid Stimulating Hormone | Produced by the pituitary gland in the brain. Tells the thyroid gland to make thyroid hormones. | Descriptive data, reflecting participant flow End of test phase (N=148, completers) | Posted | Median | Inter-Quartile Range | ulU/ml | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Reverse T3 | thyroid function test, inactive form of triiodothyronine (T3) Lifespan Bio kit was used for analysis. The range of this kit is 250 to 5000 pg/mL, which varies from other commercially available kits (about 10-fold greater values). | Descriptive data, reflecting participant flow End of test phase (N=148, completers minus 1 participant in the High carbohydrate diet group for whom reverse T3 result is missing) | Posted | Median | Inter-Quartile Range | pg/mL | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Urinary Cortisol Excretion | cortisol (stress hormone) excreted in the urine over a 24-hour period | Descriptive data, reflecting participant flow End of test phase (N=148, completers) | Posted | Median | Inter-Quartile Range | μg/d | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Urinary Catecholamine - Adrenaline | catecholamine excreted in the urine over 24 hours, also known as epinephrine | Descriptive data, reflecting participant flow End of test phase (N=148, completers) | Posted | Median | Inter-Quartile Range | mcg/day | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Urinary Catecholamine - Dopamine | catecholamine excreted in the urine over 24 hours | Descriptive data, reflecting participant flow End of test phase (N=148, completers) | Posted | Median | Inter-Quartile Range | mcg/day | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Urinary Catecholamine - Noradrenaline | catecholamine excreted in the urine over 24 hours, also known as norepinephrine | Descriptive data, reflecting participant flow End of test phase (N=148, completers) | Posted | Median | Inter-Quartile Range | mcg/day | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Secondary | Insulin Sensitivity (Hepatic), Assessed by Frequently-sampled Oral Glucose Tolerance Test | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Insulin Sensitivity (Systemic), Assessed by Frequently-sampled Oral Glucose Tolerance Test | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Non-esterified Fatty Acids | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Serum Ketones/Ketoacids | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Lactate | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Metabolic Fuel Concentration in Serum (Glucose, Nonesterified Fatty Acids, Ketones/Ketoacids, Lactate) | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Insulin-like Growth Factor 1 (IGF-1) | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | IGF Binding Proteins | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Testosterone | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Estradiol | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Luteinizing Hormone | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Follicle Stimulating Hormone | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Body Weight Change During ad Libitum Feeding | Not Posted | Dec 2026 | Ad libitum feeding period (weeks 21 and 22 following randomization) | Participants |
| Secondary | Gut Microbiome Profile | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Serum Metabolomics Profile | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Change in Cognitive Function Related to Memory | California Verbal Learning Test - Second Edition [CVLT-II] and Digit Span Test | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Change in Cognitive Function Related to Processing Speed and Executive Function | Trail Making Test Parts A and B [TMT-A, TMT-B] | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Change in Self-reported Sleep Quality | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Change in Self-reported Depression Measure | Beck Depression Inventory-II [BDI-II] | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Change in Self-reported Mood/Anxiety | Mood and Anxiety Symptom Questionnaire [MASQ] | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Change in Self-reported Food Addiction Score | Yale Food Addiction Scale [YFAS] | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Change in Self-reported Emotional Eating Score | Emotional Eating Scale [EES] | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Secondary | Change in Self-reported Binge Eating Score | Binge Eating Scale [BES] | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Other Pre-specified | Effect Modification by Insulin Secretion of Metabolic Responses to Diet | Effect modifier: Insulin level 30 minutes into an standard OGTT (Insulin-30) Outcome: Total Energy Expenditure Tertiles: Pre-weight-loss Insulin-30 (Low, Moderate, High) Change: average (midpoint of test phase, end of test phase) - start of trial | The outcome is "Effect Modification by Insulin Secretion." Thus,participants were divided into tertiles of Insulin-30. Tertile I: Low=17, Moderate=16, High=22 Tertile II: Low=15, Moderate=22, High=17 Tertile III: Low=24, Moderate=14, High=15 | Posted | Mean | 95% Confidence Interval | kcal/d | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance |
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| Other Pre-specified | Effect Modification by Insulin Resistance of Metabolic Responses to Diet | Not Posted | Dec 2026 | Start of (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| Other Pre-specified | Effect Modification by Amylase Gene Copy Number | Not Posted | Dec 2026 | Start of trial (time of randomization, post-weight loss) through 20 weeks' weight loss maintenance | Participants |
| 0 |
| 234 |
| 0 |
| 234 |
| 28 |
| 234 |
| EG001 | Low Carbohydrate Diet | Feeding study: Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein. | 0 | 57 | 0 | 57 | 5 | 57 |
| EG002 | Moderate Carbohydrate Diet | Feeding study: Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein. | 0 | 53 | 0 | 53 | 6 | 53 |
| EG003 | High Carbohydrate Diet | Feeding study: Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein | 0 | 54 | 2 | 54 | 1 | 54 |
| Removal of intrauterine device | Reproductive system and breast disorders | Systematic Assessment |
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| Food allergy, aversion or intolerance | Immune system disorders | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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| Mood changes | General disorders | Systematic Assessment |
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| Increased blood cholesterol | Metabolism and nutrition disorders | Systematic Assessment |
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| Possible gall bladder disease | General disorders | Systematic Assessment |
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| Possible hypoglycemia | Endocrine disorders | Systematic Assessment |
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| Hematoma | General disorders | Systematic Assessment |
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| Vasovagal reaction | Nervous system disorders | Systematic Assessment |
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| Vomiting | General disorders | Systematic Assessment |
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| Lightheadedness | General disorders | Systematic Assessment |
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| Migraine | General disorders | Systematic Assessment |
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| Bone fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| High blood pressure | Vascular disorders | Systematic Assessment |
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| Ankle sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Tested to rule out meningitis | Surgical and medical procedures | Systematic Assessment |
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| Possible post-viral lactose intolerance | Metabolism and nutrition disorders | Systematic Assessment |
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| Food intolerance | General disorders | Systematic Assessment |
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| Hypertension (new prescription medication) | General disorders | Systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pericarditis | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Change, 20 weeks |
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| Change, 20 weeks |
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| Change, 20 weeks |
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| Change, 20 weeks |
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| Systolic, Change |
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| Diastolic, Start of trial |
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| Diastolic, Change |
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| Start of trial |
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| End of test phase |
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| End of test phase |
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| End of test phase |
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| End of test phase |
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| End of test phase |
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| End of test phase |
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| End of test phase |
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| End of test phase |
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| End of test phase |
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| Change, Low Insulin-30 |
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| Start of Trial, Moderate Insulin-30 |
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| Change, Moderate Insulin-30 |
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| Start of Trial, High Insulin-30 |
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| Change, High Insulin-30 |
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