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 range
20 Years – 65 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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