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Individual Metabolism and Physiology Signature Study

Information source: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Insulin Resistance; Metabolic Syndrome X; Obesity

Intervention: DGA Diet Plan (Other); NHANES Diet Plan (Other)

Phase: N/A

Status: Recruiting

Sponsored by: USDA, Western Human Nutrition Research Center

Official(s) and/or principal investigator(s):
Nancy L Keim, PhD, Principal Investigator, Affiliation: USDA, Western Human Nutrition Research Center

Overall contact:
Nancy L Keim, PhD, Phone: (530) 752-4163, Email: nancy.keim@ars.usda.gov


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.

Clinical Details

Official title: Individual Metabolism and Physiology Signature Study

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: Change in Fasting Insulin Concentrations

Secondary outcome: Change in Lipid Profile

Detailed 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.


Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Female.


Inclusion Criteria:

- Premenopausal by self-report

- Body Mass Index 27-37. 5 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 <27 and >37. 5 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

Locations and Contacts

Nancy L Keim, PhD, Phone: (530) 752-4163, Email: nancy.keim@ars.usda.gov

Western Human Nutrition Research Center, Davis, California 95616, United States; Recruiting
Ellen L Bonnel, PhD, Phone: 530-752-4184, Email: ellen.bonnel@ars.usda.gov
Nancy L Keim, PhD, Principal Investigator

Clinical Translational Science Center, Sacramento, California 95817, United States; Recruiting
Nicole Hansen, RN, Phone: 916-703-5595, Email: nicole.hansen@ucdmc.ucdavis.edu

Additional Information

USDA Western Human Nutrition Research Center

Starting date: December 2014
Last updated: June 30, 2015

Page last updated: August 23, 2015

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