Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-01 @ 8:09 PM
Study NCT ID:
NCT06259435
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modulating Energy Density in Time-Restricted Eating
Sponsor:
Pennington Biomedical Research Center
Organization:
Study Overview
Official Title:
Modulating Energy Density in Time-Restricted Eating
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDITRE
Brief 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
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: