Status:
COMPLETED
Individual Metabolism and Physiology Signature Study
Lead Sponsor:
USDA, Western Human Nutrition Research Center
Collaborating Sponsors:
Dairy Research Institute
University of California, Davis
Conditions:
Insulin Resistance
Metabolic Syndrome X
Eligibility:
FEMALE
20-65 years
Phase:
NA
Brief 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...
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 16 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2017
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02298725
Start Date
December 16 2014
End Date
March 30 2017
Last Update
September 29 2021
Active Locations (2)
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1
Western Human Nutrition Research Center
Davis, California, United States, 95616
2
Clinical Translational Science Center
Sacramento, California, United States, 95817