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| Name | Class |
|---|---|
| Dairy Research Institute | OTHER |
| University of California, Davis | OTHER |
| University of Arkansas | OTHER |
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To determine if consumption of different diet plans that both are nutritionally-adequate and provide energy to maintain body weight, alters fasting insulin concentrations, shifts other common clinical markers of metabolic disease risk, and affects metabolomic profiles that reflect glucose, lipid, and amino acid metabolism.
Western Human Nutrition Research Center (WHNRC) scientists have observed rapid and substantial improvements in metabolic health indices in non-diabetic obese persons who undergo a weight-maintenance diet including prepared meals that were aligned with current dietary recommendations, including those of the Institute of Medicine and the United States Department of Agriculture (USDA) and Department of Health and Human Services (DHHS) Dietary Guidelines for Americans. For instance, marked reductions and often normalization of hyperinsulinemia were observed within days of provision of a controlled nutrient-dense high quality diet, and LDL was reduced by 20-30% or more within 2 weeks or possibly earlier. This indicates that change in diet alone would benefit many at-risk persons with respect to normalizing metabolic parameters and disease risk markers. Yet, surprisingly little formal research has focused on how a high quality, weight maintaining diet impacts health over a short-term period in at-risk individuals. The overall objective of this study is to determine if a nutrient-adequate diet closely aligned with food group recommendations set in the 2010 Dietary Guidelines for Americans elicits a superior metabolic profile in persons at-risk for metabolic disease, compared to a nutrient-adequate containing foods closely aligned with the National Health and Nutrition Examination Survey (NHANES) "What We Eat In America" report. Further, the investigation will include effect modification of stress-related cortisol measures on change in cardiometabolic risk factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DGA Diet Plan | Experimental | A nutrient-adequate, balanced diet providing energy to maintain body weight, and macronutrient composition falling within the acceptable range, as recommended by the Institute of Medicine. The foods provided in this diet will be closely aligned with food group recommendations set in the 2010 Dietary Guidelines for Americans. All foods and beverages will be provided to enrolled subjects during the intervention period. |
|
| NHANES Diet Plan | Experimental | A nutrient-adequate, balanced diet providing energy to maintain body weight, and macronutrient composition falling within the acceptable range, as recommended by the Institute of Medicine. The foods provided in this diet plan will be closely aligned with the NHANES "What We Eat In America" report. All foods and beverages will be provided to enrolled subjects during the intervention period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DGA Diet Plan | Other | A nutrient-adequate, balanced diet providing energy to maintain body weight, and macronutrient composition falling within the acceptable range, as recommended by the Institute of Medicine. The foods provided in this diet will be closely aligned with food group recommendations set in the 2010 Dietary Guidelines for Americans. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Insulin Concentrations | Additional indicators of glucose-insulin sensitivity will be assessed including the Quantitative Insulin Sensitivity Check Index (QUICKI) score, Homeostasis Model Assessment (HOMA), and Matsuda Index | Weeks 1, 3, and 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lipid Profile | fasting triglyceride concentrations, LDL cholesterol, HDL cholesterol will be measured in serum as a composite measurement | Weeks 1, 3, and 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Metabolomic Profile | Endocannabinoids, Bile Acids, Amino Acids, Acyl Carnitines, Non-Esterified Fatty Acids, Oxylipins, Corticoids, Nitrate/Nitrite, and Tissue Lipid Profile will be measured in plasma, erythrocytes, and sebaceous secretions as a composite measurement. | Weeks 1,3, and 9 |
| Change in Immunological Markers |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy L Keim, PhD | USDA, Western Human Nutrition Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Western Human Nutrition Research Center | Davis | California | 95616 | United States | ||
| Clinical Translational Science Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32190808 | Background | Krishnan S, Lee F, Burnett DJ, Kan A, Bonnel EL, Allen LH, Adams SH, Keim NL. Challenges in Designing and Delivering Diets and Assessing Adherence: A Randomized Controlled Trial Evaluating the 2010 Dietary Guidelines for Americans. Curr Dev Nutr. 2020 Feb 13;4(3):nzaa022. doi: 10.1093/cdn/nzaa022. eCollection 2020 Mar. | |
| 36575541 |
| Label | URL |
|---|---|
| USDA Western Human Nutrition Research Center | View source |
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D024821 | Metabolic Syndrome |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D018673 | Nutrition Policy |
| ID | Term |
|---|---|
| D006291 | Health Policy |
| D011640 | Public Policy |
| D011049 | Social Control Policies |
| D057766 | Policy |
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|
| NHANES Diet Plan | Other | A nutrient-adequate, balanced diet providing energy to maintain body weight, and macronutrient composition falling within the acceptable range, as recommended by the Institute of Medicine. The foods provided in this diet will be closely aligned with the NHANES "What we eat in America" report. |
|
Immunologic markers such as tumor necrosis factor-α, Interleukin-β, Interleukin-6, Interferon-γ, Interleukin-13, Interleukin-17A, Interleukin-10 will be measured in plasma and whole cell preparations as a composite measurement. |
| Weeks 1 and 9 |
| Bio-Behavioral responses to diet intervention | Stress Reactivity, Allostatic Load, Autonomic Nervous System Output, and Cognitive Function will be recorded as a composite measurement. | Weeks 1 and 9 |
| Change in responses to Behavioral questionnaires | Appetite, Food Preference, Diet Bias will be measured and reported as a composite measurement. | Weeks 1, 3, and 9 |
| Change in Taste preference threshold | Sweet, salty, and bitter taste sensitivity will be evaluated using the three-alternative-forced choice method for determining recognition taste thresholds | Weeks 1 and 9 |
| Change in intestinal microbiota | Assays will be performed on fecal samples to determine DNA representing the colonic microbiota, amount of organic acids and other metabolites of fermentation. | weeks 1, 3, 5 and 9 |
| Change in usual physical activity | Usual physical activity will be measured by accelerometer worn for 7 days | weeks 1, 3, and 9 |
| Change in body composition | Body composition (total body fat) will be measured by dual energy x-ray absorptiometry (DXA) | weeks 1 and 9 |
| Change in vascular function | Vascular function assessment of peripheral arterial tone (PAT) measurement conducted at resting conditions and after a reactive hyperemia | weeks 1 and 9 |
| Change in Framingham Risk Score | Calculated Framingham 10-year cardiovascular disease risk score | weeks 1, 3 and 9 |
| Change in vascular age score | Calculated vascular age score | weeks 1, 3 and 9 |
| Change in metabolic rate | Respiratory gas exchange measurements (oxygen consumption and carbon dioxide production) will be measured in response to a test meal | weeks 1, 3, and 9 |
| Change in breath volatile gases | Alveolar air (breath) samples will be analyzed for hydrogen and methane, products produced by bacterial fermentation of carbohydrates in the gastrointestinal tract | weeks 1, 3, and 9 |
| Usual diet | Usual diet will be measured once by food frequency questionnaire and 24 hour recall methodology | week 1 |
| Change in post-translational glycosylation of select serum proteins (glycoproteome) | Serum circulating protein concentrations and their glycovariant distributions measured by Ultra High Pressure Liquid Chromatography - Mass Spectrometry (UHPLC-MS). Proteins selected based on their association to chronic metabolic disease, such as angiotensinogen, fibronectin, kininogen, kallikrein, apolipoprotein CIII, fetuin and vitronectin. | weeks 1, 3 and 9 |
| Change in Trimethylamine Oxide (TMAO) | Fasting serum level of TMAO measured by liquid chromatography mass spectrometry (LCMS) | weeks 1, 3 and 9 |
| Change in choline | Fasting serum level of choline measured by liquid chromatography mass spectrometry (LCMS) | weeks 1, 3 and 9 |
| Change in carnitine | Fasting serum level of carnitine measured by liquid chromatography mass spectrometry (LCMS) | weeks 1, 3 and 9 |
| Change in betaine | Fasting serum level of betaine measured by liquid chromatography mass spectrometry (LCMS) | weeks 1, 3 and 9 |
| Change in creatinine | Fasting serum level of creatinine measured by liquid chromatography mass spectrometry (LCMS) | weeks 1, 3 and 9 |
| Fasting urinary cortisol | Cortisol was measured in 12-hour overnight urine samples collected prior to eating | weeks 1 and 9 |
| Baseline and change in diurnal salivary cortisol | Cortisol was measured in saliva samples collected using a cotton swab (Salivette) | weeks 1 and 9; at nighttime before going to sleep and upon waking |
| Baseline and change in salivary cortisol response to a meal | Cortisol was measured in saliva samples collected using a cotton swab (Salivette) | weeks 1 and 9; at 60, 90, and 120 minutes after the initiation of a meal |
| Baseline and change in salivary cortisol response to stress | Cortisol was measured in saliva samples collected using a cotton swab (Salivette) | weeks 1 and 9; at 30, 60, 90, and 120 minutes after the start of a stress test |
| Sacramento |
| California |
| 95817 |
| United States |
| Krishnan S, Freytag T, Jiang X, Schuster GU, Woodhouse LR, Keim NL, Stephensen CB. Effect of a diet based on the dietary guidelines for americans on inflammation markers in women at risk for cardiometabolic disease: results of a randomized, controlled trial. BMC Nutr. 2022 Dec 27;8(1):157. doi: 10.1186/s40795-022-00647-z. |
| 35634390 | Result | Newman JW, Krishnan S, Borkowski K, Adams SH, Stephensen CB, Keim NL. Assessing Insulin Sensitivity and Postprandial Triglyceridemic Response Phenotypes With a Mixed Macronutrient Tolerance Test. Front Nutr. 2022 May 11;9:877696. doi: 10.3389/fnut.2022.877696. eCollection 2022. |
| 35187036 | Result | Richardson CE, Krishnan S, Gray IJ, Keim NL, Newman JW. The Omega-3 Index Response to an 8 Week Randomized Intervention Containing Three Fatty Fish Meals Per Week Is Influenced by Adiposity in Overweight to Obese Women. Front Nutr. 2022 Feb 4;9:810003. doi: 10.3389/fnut.2022.810003. eCollection 2022. |
| 34895998 | Result | Krishnan S, Gertz ER, Adams SH, Newman JW, Pedersen TL, Keim NL, Bennett BJ. Effects of a diet based on the Dietary Guidelines on vascular health and TMAO in women with cardiometabolic risk factors. Nutr Metab Cardiovasc Dis. 2022 Jan;32(1):210-219. doi: 10.1016/j.numecd.2021.09.013. Epub 2021 Sep 20. |
| 31652899 | Result | Soltani H, Keim NL, Laugero KD. Increasing Dietary Carbohydrate as Part of a Healthy Whole Food Diet Intervention Dampens Eight Week Changes in Salivary Cortisol and Cortisol Responsiveness. Nutrients. 2019 Oct 24;11(11):2563. doi: 10.3390/nu11112563. |
| 30388762 | Result | Soltani H, Keim NL, Laugero KD. Diet Quality for Sodium and Vegetables Mediate Effects of Whole Food Diets on 8-Week Changes in Stress Load. Nutrients. 2018 Nov 1;10(11):1606. doi: 10.3390/nu10111606. |
| 30101333 | Result | Krishnan S, Adams SH, Allen LH, Laugero KD, Newman JW, Stephensen CB, Burnett DJ, Witbracht M, Welch LC, Que ES, Keim NL. A randomized controlled-feeding trial based on the Dietary Guidelines for Americans on cardiometabolic health indexes. Am J Clin Nutr. 2018 Aug 1;108(2):266-278. doi: 10.1093/ajcn/nqy113. |
| 35669046 | Derived | Soltani H, Keim NL, Laugero KD. Waking Salivary Cortisol Associated with Magnitude of Cholesterol Reduction in Women Fed a Healthy Whole-Food Diet for 8 Weeks. Curr Dev Nutr. 2022 May 3;6(5):nzac083. doi: 10.1093/cdn/nzac083. eCollection 2022 May. |
| 34154665 | Derived | Artegoitia VM, Krishnan S, Bonnel EL, Stephensen CB, Keim NL, Newman JW. Healthy eating index patterns in adults by sex and age predict cardiometabolic risk factors in a cross-sectional study. BMC Nutr. 2021 Jun 22;7(1):30. doi: 10.1186/s40795-021-00432-4. |
| 33770218 | Derived | Kim T, Xie Y, Li Q, Artegoitia VM, Lebrilla CB, Keim NL, Adams SH, Krishnan S. Diet affects glycosylation of serum proteins in women at risk for cardiometabolic disease. Eur J Nutr. 2021 Oct;60(7):3727-3741. doi: 10.1007/s00394-021-02539-7. Epub 2021 Mar 26. |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004472 |
| Health Care Economics and Organizations |