CompletedNot Applicable

Lifestyle Intervention for Improving Insulin Resistance and Concern for Health

United States40 participantsStarted 2023-02-13

Plain-language 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: 1. Does the diet and exercise program improve insulin resistance and apathy? 2. 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: 1. A diet to moderate the blood glucose response that contains soybean; and 2. A diet to moderate the blood glucose response that does not contain soybean.

Who can participate

Age range50 Years – 75 Years

SexALL

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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: * Body mass index (BMI) greater than or equal to 30kg/m2 * Mini-Mental State Examination (MMSE) \> 25 * Geriatric Depression Scale-15 (GDS-15) \< 6 * Apathy Evaluation Scale - score \> 30 or GDS-15 Apathy subscale - score ≥ 2 * Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3 * Sedentary: \< 90 minutes of moderate to vigorous physical activity/week. Exclusion Criteria: * Subjects with a diagnosis of Type 2 diabetes received more than five years ago. * Participants who have type 1 diabetes * Participants 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.

What they're measuring

Insulin sensitivity

Timeframe: 12 weeks

Apathy

Timeframe: 12 weeks

Trial details

NCT IDNCT05649176

SponsorPennington Biomedical Research Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-27