Individual Metabolism and Physiology Signature Study



Status:Recruiting
Conditions:Obesity Weight Loss, Endocrine, Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:20 - 65
Updated:4/21/2016
Start Date:December 2014
End Date:September 2017
Contact:Nancy L Keim, PhD
Email:nancy.keim@ars.usda.gov
Phone:(530) 752-4163

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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.

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
We found this trial at
2
sites
Davis, California 95616
Principal Investigator: Nancy L Keim, PhD
Phone: 530-752-4184
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Sacramento, California 95817
Phone: 916-703-5595
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