Individual Metabolism and Physiology Signature Study
Completed · Not applicable
Conditions studied: Insulin Resistance, Metabolic Syndrome X, Obesity
In brief
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.
Key facts
- Study ID
- NCT02298725
- Run by
- USDA, Western Human Nutrition Research Center
- People needed
- 52
- Starts
- 2014-12-16
- Expected to finish
- 2017-03-30
- Last updated by the study team
- 2026-03-25
Who can join
Age: 20 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Western Human Nutrition Research Center — Davis, California, United States
- Clinical Translational Science Center — Sacramento, California, United States
Full record on ClinicalTrials.gov
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