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Not Yet Recruiting NCT05649176

Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

Conditions: Insulin Sensitivity, Apathy

Sex: All
Ages: 50 Years – 75 Years
Phase: NA
Enrollment: 40
Sponsor: Pennington Biomedical Research Center

Summary

The primary objective of this study is to test the effect of a diet and exercise program in older adults with insulin resistance and a motivation disorder known as apathy. The main questions the study aims to answer are:Does the diet and exercise program improve insulin resistance and apathy?Does the addition of soybean to the diet enhance the effect? Participants will be given all meals for 12 weeks and will exercise under supervision. They will undergo a test of insulin sensitivity and complete questionnaires.Researchers will compare the groups given:A diet to moderate the blood glucose response that contains soybean; andA diet to moderate the blood glucose response that does not contain soybean.

Eligibility Criteria

Inclusion Criteria:Body mass index (BMI) from 30 to 40 kg/m2No evidence of diabetes (fasting blood sugar <126 mg/dL)Mini-Mental State Examination (MMSE) > 25Geriatric Depression Scale-15 (GDS-15) < 6Apathy Evaluation Scale - score > 30Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3Sedentary: < 90 minutes of moderate to vigorous physical activity/week.Exclusion Criteria:Prior history of type 2 diabetes.Participants who have type 1 diabetesParticipants being treated with prescription or over the counter medications that have a significant effect on insulin resistance, obesity, high density lipoprotein cholesterol, triglycerides, metabolic rate and those that significantly increase body weight.Participants who are on concomitant therapy with glucocorticoids.Participants with evidence and/or history (within the preceding 6 months) of significant gastrointestinal dysfunction.Participants that have had a fluctuation in body weight >5% in the preceding 2 months.Any other conditions that may impede testing of the study hypothesis.

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Source: ClinicalTrials.gov (NCT05649176). StuddyBuddy aggregates publicly available trial information.