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 range

50 Years – 75 Years

Sex

ALL

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: * 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.

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

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

View on ClinicalTrials.gov More Insulin Sensitivity trials