Individual Metabolism and Physiology Signature Study (NCT02298725) | Clinical Trial Compass
CompletedNot Applicable
Individual Metabolism and Physiology Signature Study
United States52 participantsStarted 2014-12-16
Plain-language summary
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.
Who can participate
Age range20 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change in Fasting Insulin Concentrations
Timeframe: Weeks 1, 3, and 9
Trial details
NCT IDNCT02298725
SponsorUSDA, Western Human Nutrition Research Center