Modulating Energy Density in Time-Restricted Eating

Launched by PENNINGTON BIOMEDICAL RESEARCH CENTER · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to see how a specific eating pattern called time-restricted eating affects older adults with obesity and insulin resistance. In this study, participants will fast for 14 hours each day and have a 10-hour window to eat. They will be divided into two groups: one group will follow this eating pattern while also eating a low-energy dense diet, which means the foods they eat will have fewer calories for the same amount of food. The second group will follow the same eating pattern but will eat the typical diet that people in this age group usually consume. The researchers want to find out if this combination helps reduce insulin resistance (which can lead to diabetes) and helps with weight loss.

To join the study, participants need to be between 18 and 93 years old with a body mass index (BMI) of 30 or higher, indicating obesity. They should also have normal cognitive function and low levels of depression. However, those with certain health conditions, such as diabetes diagnosed more than five years ago or serious kidney problems, cannot participate. Those who join can expect to follow the eating plan for a set period while being monitored by the research team. This study is currently looking for volunteers, and it's a chance to contribute to understanding how diet can impact health in older adults.

Gender

ALL

Eligibility 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)