Individual Metabolism and Physiology Signature Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Individual Metabolism and Physiology Signature Study

Conditions
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Insulin Resistance, Metabolic Syndrome X, Obesity

Intervention / Treatment
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* Other: DGA Diet Plan
* Other: NHANES Diet Plan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Premenopausal by self-report Body Mass Index 25-39.9 kg/m2 Fasting glucose ≥100 and <126 mg/dL and/or Oral Glucose Tolerance Test (OGTT) 2-hour glucose ≥140 and <199 mg/dL and/or Quantitative insulin sensitivity check index (QUICKI) score <0.315 and/or Homeostasis Model Assessment (HOMA) >3.67, or log HOMA >0.085 and/or Glycated Hemoglobin HbA1c ≥5.7 and <6.5fasting glucose ≥100 and <126 mg/dL and/or Fasting triglyceride concentrations >150 mg/dL and/or LDL cholesterol >100 mg/dL and/or HDL cholesterol <40 mg/dL. Exclusion Criteria: BMI <25 and >39.9 kg/m2 Presence of any metabolic diseases, by self-report Gastrointestinal disorders by self-report Presence of cancer or other serious chronic disease by self-report Current use of prescribed or over the counter weight loss medications Pregnant Lactating Current use of tobacco Moderate or strenuous physical activity >30 min/day, 5 or more days per week Weight change >5% of body weight during the previous 6 months Dietary restrictions that would interfere with consuming the intervention foods

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DGA Diet Plan<br>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<br>* 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.<br>* Other names: Dietary Guidelines for Americans Diet Plan;|
| Experimental: NHANES Diet Plan<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin Resistance, Obesity, US Dietary Guidelines