An interventional study of DGA Diet Plan and NHANES Diet Plan in Insulin Resistance, Metabolic Syndrome X and Obesity, sponsored by USDA, Western Human Nutrition Research Center. Completed at 2 sites in United States. Open to female participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by USDA, Western Human Nutrition Research Center · Not applicable, Interventional, and Basic science
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.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's enrollment of 52 is below the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →USDA, Western Human Nutrition Research Center is the lead sponsor of 54 studies on the registry; 1 is open to participants now.
Compared within Metabolic Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Insulin Resistance. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: DGA Diet Plan
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.
Other: NHANES Diet Plan
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.
Also known as: Dietary Guidelines for Americans Diet Plan
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.
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
Time frame: Weeks 1, 3, and 9
Change in Lipid Profile
fasting triglyceride concentrations, LDL cholesterol, HDL cholesterol will be measured in serum as a composite measurement
Time frame: Weeks 1, 3, and 9
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.
Time frame: Weeks 1,3, and 9
Change in Immunological Markers
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.
Time frame: 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.
Time frame: Weeks 1 and 9
Change in responses to Behavioral questionnaires
Appetite, Food Preference, Diet Bias will be measured and reported as a composite measurement.
Time frame: 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
Time frame: 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.
Time frame: weeks 1, 3, 5 and 9
Change in usual physical activity
Usual physical activity will be measured by accelerometer worn for 7 days
Time frame: weeks 1, 3, and 9
Change in body composition
Body composition (total body fat) will be measured by dual energy x-ray absorptiometry (DXA)
Time frame: 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
Time frame: weeks 1 and 9
Change in Framingham Risk Score
Calculated Framingham 10-year cardiovascular disease risk score
Time frame: weeks 1, 3 and 9
Change in vascular age score
Calculated vascular age score
Time frame: 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
Time frame: 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
Time frame: weeks 1, 3, and 9
Usual diet
Usual diet will be measured once by food frequency questionnaire and 24 hour recall methodology
Time frame: 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.
Time frame: weeks 1, 3 and 9
Change in Trimethylamine Oxide (TMAO)
Fasting serum level of TMAO measured by liquid chromatography mass spectrometry (LCMS)
Time frame: weeks 1, 3 and 9
Change in choline
Fasting serum level of choline measured by liquid chromatography mass spectrometry (LCMS)
Time frame: weeks 1, 3 and 9
Change in carnitine
Fasting serum level of carnitine measured by liquid chromatography mass spectrometry (LCMS)
Time frame: weeks 1, 3 and 9
Change in betaine
Fasting serum level of betaine measured by liquid chromatography mass spectrometry (LCMS)
Time frame: weeks 1, 3 and 9
Change in creatinine
Fasting serum level of creatinine measured by liquid chromatography mass spectrometry (LCMS)
Time frame: weeks 1, 3 and 9
Fasting urinary cortisol
Cortisol was measured in 12-hour overnight urine samples collected prior to eating
Time frame: weeks 1 and 9
Baseline and change in diurnal salivary cortisol
Cortisol was measured in saliva samples collected using a cotton swab (Salivette)
Time frame: 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)
Time frame: 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)
Time frame: weeks 1 and 9; at 30, 60, 90, and 120 minutes after the start of a stress test
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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USDA, Western Human Nutrition Research Center