Testing a low-energy diet with time-restricted eating in older adults
Modulating Energy Density in Time-Restricted Eating
NA · Pennington Biomedical Research Center · NCT06259435
This study is testing if a low-energy diet combined with time-restricted eating can help older adults with obesity improve their insulin resistance and lose weight.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Pennington Biomedical Research Center (other) |
| Locations | 1 site (Baton Rouge, Louisiana) |
| Trial ID | NCT06259435 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to evaluate the effects of a low-energy dense diet combined with time-restricted eating on insulin resistance and body weight in older adults with obesity. Participants will undergo an eight-week intervention where they will be assigned to either a low-energy dense diet or their usual diet while following a 14-hour fasting and 10-hour eating window. The study will monitor dietary compliance through meal preparation in a metabolic kitchen and will assess changes in insulin resistance and body weight through blood samples and measurements before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are older adults with a body mass index (BMI) of 30 kg/m² or higher and insulin resistance.
Not a fit: Patients with a recent diagnosis of Type 2 diabetes, significant renal dysfunction, or those on specific medications for obesity may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to effective dietary strategies for managing obesity and insulin resistance in older adults.
How similar studies have performed: Other studies have shown promising results with time-restricted eating and dietary modifications, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Body mass index (BMI) ≥ 30kg/m2. 2. Mini-Mental State Examination (MMSE) \> 25 3. Geriatric Depression Scale-15 (GDS-15) \< 9 4. Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3. Exclusion Criteria: 1. Diagnosis of Type 2 diabetes received more than five years ago 2. Diagnosis of type 1 diabetes 3. Evidence of clinically significant renal dysfunction or disease 4. History of malignancy during the past five years 5. Being treated with systemic steroids, olanzapine, or clozapine 6. Being treated with prescription medications for obesity 7. Being treated with thiazolidinediones, glucagon-like-receptor agonists, Dipeptidyl Peptidase IV inhibitors, and insulin 8. Weight change \> 3 kg in the preceding three months 9. Any disease or condition that precludes testing of the study outcomes or makes it unsafe to consume the foods being tested in the study, or subjects are otherwise deemed to be unsuitable for participation in the study (determined by the investigative team)
Where this trial is running
Baton Rouge, Louisiana
- Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (RECRUITING)
Study contacts
- Principal investigator: Candida Rebello — Pennington Biomedical Research Center
- Study coordinator: Candida J Rebello, Ph.D.
- Email: Candida.Rebello@pbrc.edu
- Phone: 2252882411
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.
Conditions: Insulin Resistance, Body Weight