Diet and exercise program to improve insulin resistance and apathy in older adults
Lifestyle Intervention for Improving Metabolic and Motivational Outcomes
This study is testing if a diet that includes soybean, along with exercise, can help older adults with obesity improve their insulin sensitivity and reduce feelings of apathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Pennington Biomedical Research Center Academic / other |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT05649176 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of a diet and exercise program on insulin sensitivity and apathy in older adults with obesity. Participants will be randomly assigned to receive either a diet that includes soybean or one that does not, alongside a supervised exercise regimen over 12 weeks. The study will measure insulin sensitivity using a hyperinsulinemic euglycemic clamp test and assess apathy through the Apathy Evaluation Scale. The goal is to determine if the inclusion of soybean enhances the benefits of the diet and exercise intervention.
Who should consider this trial
Good fit: Ideal candidates are older adults with a BMI of 30 or greater, insulin resistance, and symptoms of apathy.
Not a fit: Patients with a diagnosis of Type 2 diabetes within the last five years or those on medications affecting insulin resistance may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve insulin resistance and reduce apathy in older adults, enhancing their overall health and quality of life.
How similar studies have performed: Previous studies have shown promising results with lifestyle interventions for insulin resistance, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Baton Rouge, Louisiana
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (Recruiting)
Study contacts
- Principal investigator: Candida J Rebello — Pennington Biomedical Research Center
- Study coordinator: Amber Dragg, PhD
- Email: Amber.Dragg@pbrc.edu
- Phone: 12257633050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.