Individual Metabolism and Physiology Signature Study (iMAPS)

USDA, Western Human Nutrition Research Center

Status: Completed

Conditions: Insulin Resistance; Obesity; Metabolic Syndrome X

Treatments: Other: NHANES Diet Plan; Other: DGA Diet Plan

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02298725

648620

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

DGA Diet Plan

Experimental group

Description:

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.

Treatment:

Other: DGA Diet Plan

NHANES Diet Plan

Experimental group

Description:

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.

Treatment:

Other: NHANES Diet Plan