NCT06259435

Modulating Energy Density in Time-Restricted Eating

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized controlled trial is to test the effect of time-restricted eating (14-hour fast, 10-hour eating window) of a low-energy dense diet (reduced calories per gram of food) in older adults with obesity and insulin resistance. The study aims to determine if modulating the energy density of the diet reduces: 1. Insulin resistance and 2. Body weight. Researchers will compare the groups: 1. Following time-restricted eating and given a diet reduced in energy density or 2. Following time-restricted eating and given a diet typically consumed in this population

Detailed description

The study is an eight-week randomized controlled double-blinded clinical trial. Participants will follow time-restricted eating (14-hour fast, 10-hour eating window), and will be randomized to a diet low in energy density or the usual diet. Meals will be prepared in a metabolic kitchen and dispensed to participants. Dietitians will monitor dietary compliance. A blood sample will be drawn and body weight will be measured before starting the intervention and after completing it.

Conditions

• Insulin Resistance
• Body Weight

Interventions

Type	Name	Description
BEHAVIORAL	Low-energy dense diet	Subjects will follow time-restricted eating of a low energy dense diet
BEHAVIORAL	Usual diet	Subjects will follow time-restricted eating of the usual diet

Timeline

• Start date: 2024-05-29
• Primary completion: 2025-12-17
• Completion: 2025-12-17
• First posted: 2024-02-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States