Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 19-DK-0067 | Other Identifier | NIH Clinical Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background:
Researchers want to learn how different diets affect hormone levels, body weight, energy expenditure, liver fat, and more. To do this, they will use specialized techniques and food plans. This is not a weight loss study.
Objective:
To better understand how low-fat and low-carbohydrate foods affect health.
Eligibility:
Men and women ages 18-50 who have a stable body weight and can exercise daily
Design:
Participants will have a screening visit that lasts 4-6 hours. It will include:
Medical history
Physical exam
Fasting blood and urine tests
Questionnaires
Trying foods from the study
Participants will be admitted to the Clinical Center and will stay for 4 weeks without leaving. They can have visitors.
Participants will wear activity and glucose monitors throughout the study. They will be weighed daily and will complete daily exercise. They will eat 3 meals daily, plus snacks. They will give urine, saliva, and blood samples. They will fill out questionnaires and rate their hunger, appetite, and sense of taste. They will have body scans. For the scans, they will lie in a machine that takes X-ray pictures of the body.
Participants will complete activities to measure how many calories they burn and how the diets affect them:
Participants will drink special liquids to measure calories burned, sugar, and sense of taste.
Participants will wear a plastic hood while resting.
Participants will stay alone in a special room for 24 hours.
Participants will eat a low-carb, high-fat diet for 2 weeks and a high-carb, low-fat diet for 2 weeks.
Participants may be dismissed if they purposefully use the study to try to change their body weight.
Sponsoring Institution: National Institute of Diabetes and Digestive and Kidney Diseases
...
Competing theories about obesity and its treatment contrast the relative roles of dietary fat versus carbohydrate on promotion of excessive calorie intake. Advocates of low-carbohydrate diets propose that diets high in carbohydrates lead to elevated insulin secretion and increased calorie intake. Alternatively, proponents of low-fat diets argue that diets high in fat promote passive overconsumption due to the high energy density and low satiety index of high-fat foods. Therefore, we will conduct a feeding study in 20 adult men and women to investigate the differences in ad libitum energy intake resulting from consuming two test diets for a pair of 2-week periods in a randomized, crossover design during a single 4-week inpatient period. The test diets presented to participants will be matched for calories and protein, but the low-carbohydrate diet (approximately10% of calories) will be high in fat (approximately75% of calories) whereas the low-fat diet will be high in carbohydrates (approximately75% of calories) and low in fat (approximately 10% of calories).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCHF diet then LFHC diet | Active Comparator | Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet |
|
| LFHC diet then LCHF diet | Active Comparator | Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCHF diet | Dietary Supplement | low-carbohydrate, high-fat (LCHF)diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ad Libitum Energy Intake | Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Glucose During Oral Glucose Tolerance Test (OGTT) | An OGTT was performed at the end of each 14 day period and the mean glucose was calculated | Day 14 |
| Change in Body Weight | Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg) |
Not provided
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Evidence of metabolic or cardiovascular disease, or disease that may influence metabolism (e.g. cancer, diabetes, thyroid disease)
Taking any prescription medication or other drug that may influence metabolism (e.g. diet/weight-loss medication, asthma medication, blood pressure medication, psychiatric medications, corticosteroids, or other medications at the discretion of the PI and/or study team)
Positive pregnancy test or lactation as determined by volunteer report (women only)
Participating in a regular exercise program (> 2h/week of vigorous activity) as determined by volunteer report
Hematocrit <37% (women only)
Hematocrit < 40% (men only)
Caffeine consumption > 300 mg/day as determined by volunteer report
Regular use of alcohol (> 2 drinks per day), tobacco (smoking or chewing) amphetamines, cocaine, heroin, or marijuana over past 6 months as determined by volunteer report
Psychological conditions such as (but not limited to) eating disorders, claustrophobia, clinical depression, bipolar disorders, that would be incompatible with safe and successful participation in this study, as determined by investigators.
Implants, devices, or foreign objects implanted in the body that interfere with the Magnetic Resonance procedures
Volunteers with strict dietary concerns (e.g. vegetarian or kosher diet, food allergies)
Volunteers unwilling or unable to give informed consent
Non-English speakers due to unavailability of required questionnaires in other languages
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kevin Hall, Ph.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40606290 | Derived | Jaime-Lara RB, Franks AT, Nawal N, Steck MC, Chao AM, Allen C, Brooks BE, Atkinson M, Courville AB, Guo J, Yang S, Marzouk M, Darcey VL, Chung S, Forde CG, Hall KD, Joseph PV. The Role of Diet and Hormones on Taste: Low Carb Compared With Low Fat Study Findings. Curr Dev Nutr. 2025 May 19;9(6):107467. doi: 10.1016/j.cdnut.2025.107467. eCollection 2025 Jun. | |
| 39755436 |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LCHF Diet Then LFHC Diet | Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet |
| FG001 | LFHC Diet Then LCHF Diet | Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LCHF Diet Then LFHC Diet | Low carbohydrate, high fat (LCHF) diet then low fat, high carbohydrate diet (LFHC) diet |
| BG001 | LFHC Diet Then LCHF Diet | Low fat, high carbohydrate diet (LFHC) diet then low carbohydrate, high fat (LCHF) diet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Ad Libitum Energy Intake | Ad libitum energy intake averaged over 14 days for each diet, measured in kilocalories (kcal) per day. | Posted | Mean | Standard Error | kcal per day | 14 days |
|
|
During each 14 day diet period
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LC Diet | Low carbohydrate diet | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Hall, PhD | NIDDK | 301-402-8248 | kevin.hall@nih.gov |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2020 | May 11, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| LFHC diet | Dietary Supplement | low-fat, high-carbohydrate (LFHC) diet |
|
| Baseline and day 14 |
| Change in Body Fat Mass | Change in body fat mass from baseline to day 14 for each diet, measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements. | Baseline and day 14 |
| Change in Cholesterol | Change in cholesterol from baseline to day 14 for each diet | Baseline and day 14 |
| Change in Triglycerides | Change in triglycerides from baseline to day 14 for each diet | Baseline and day 14 |
| Change in TSH | Change in thyroid stimulating hormone (TSH) from baseline to day 14 for each diet | Baseline and day 14 |
| Change in C-peptide | Change in C-peptide from baseline to day 14 for each diet | Baseline and day 14 |
| Change in CRP | Change in C-reactive protein (CRP) from baseline to day 14 for each diet | Baseline and day 14 |
| Hengist A, Ong JA, McNeel K, Guo J, Hall KD. Imprecision nutrition? Intraindividual variability of glucose responses to duplicate presented meals in adults without diabetes. Am J Clin Nutr. 2025 Jan;121(1):74-82. doi: 10.1016/j.ajcnut.2024.10.007. Epub 2024 Dec 2. |
| 39163976 | Derived | Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order significantly affects energy balance for diets varying in macronutrients but not ultraprocessing in crossover studies without a washout period. Am J Clin Nutr. 2024 Oct;120(4):953-963. doi: 10.1016/j.ajcnut.2024.08.013. Epub 2024 Aug 18. |
| 38291301 | Derived | Link VM, Subramanian P, Cheung F, Han KL, Stacy A, Chi L, Sellers BA, Koroleva G, Courville AB, Mistry S, Burns A, Apps R, Hall KD, Belkaid Y. Differential peripheral immune signatures elicited by vegan versus ketogenic diets in humans. Nat Med. 2024 Feb;30(2):560-572. doi: 10.1038/s41591-023-02761-2. Epub 2024 Jan 30. |
| 37986904 | Derived | Sciarrillo CM, Guo J, Hengist A, Darcey VL, Hall KD. Diet order affects energy balance in randomized crossover feeding studies that vary in macronutrients but not ultra-processing. medRxiv [Preprint]. 2023 Oct 4:2023.10.03.23296501. doi: 10.1101/2023.10.03.23296501. |
| 37276937 | Derived | O'Connor LE, Hall KD, Herrick KA, Reedy J, Chung ST, Stagliano M, Courville AB, Sinha R, Freedman ND, Hong HG, Albert PS, Loftfield E. Metabolomic Profiling of an Ultraprocessed Dietary Pattern in a Domiciled Randomized Controlled Crossover Feeding Trial. J Nutr. 2023 Aug;153(8):2181-2192. doi: 10.1016/j.tjnut.2023.06.003. Epub 2023 Jun 3. |
| 33479499 | Derived | Hall KD, Guo J, Courville AB, Boring J, Brychta R, Chen KY, Darcey V, Forde CG, Gharib AM, Gallagher I, Howard R, Joseph PV, Milley L, Ouwerkerk R, Raisinger K, Rozga I, Schick A, Stagliano M, Torres S, Walter M, Walter P, Yang S, Chung ST. Effect of a plant-based, low-fat diet versus an animal-based, ketogenic diet on ad libitum energy intake. Nat Med. 2021 Feb;27(2):344-353. doi: 10.1038/s41591-020-01209-1. Epub 2021 Jan 21. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Mean Glucose During Oral Glucose Tolerance Test (OGTT) | An OGTT was performed at the end of each 14 day period and the mean glucose was calculated | Posted | Mean | Standard Error | mg/dl | Day 14 |
|
|
|
| Secondary | Change in Body Weight | Change in body weight from baseline to day 14 for each diet, measured in kilograms (kg) | Posted | Mean | Standard Error | kg | Baseline and day 14 |
|
|
|
| Secondary | Change in Body Fat Mass | Change in body fat mass from baseline to day 14 for each diet, measured in kilograms (kg). Body fat mass was measured using Dual-energy X-ray absorptiometry (DXA) measurements. | Posted | Mean | Standard Error | kg | Baseline and day 14 |
|
|
|
| Secondary | Change in Cholesterol | Change in cholesterol from baseline to day 14 for each diet | Posted | Mean | Standard Error | mg/dl | Baseline and day 14 |
|
|
|
| Secondary | Change in Triglycerides | Change in triglycerides from baseline to day 14 for each diet | Posted | Mean | Standard Error | mg/dl | Baseline and day 14 |
|
|
|
| Secondary | Change in TSH | Change in thyroid stimulating hormone (TSH) from baseline to day 14 for each diet | Posted | Mean | Standard Error | uIU/ml | Baseline and day 14 |
|
|
|
| Secondary | Change in C-peptide | Change in C-peptide from baseline to day 14 for each diet | Posted | Mean | Standard Error | ng/ml | Baseline and day 14 |
|
|
|
| Secondary | Change in CRP | Change in C-reactive protein (CRP) from baseline to day 14 for each diet | Posted | Mean | Standard Error | mg/l | Baseline and day 14 |
|
|
|
| 21 |
| 0 |
| 21 |
| 1 |
| 21 |
| EG001 | LF Diet | Low fat diet | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided