Modulating Energy Density in Time-Restricted Eating

NCT ID: NCT06259435

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-29
• Study Completion Date: 2025-12-17

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Low energy dense diet

Subjects will be required to follow time-restricted eating and receive a diet low in energy density

Group Type: EXPERIMENTAL

Low-energy dense diet

Intervention Type: BEHAVIORAL

Subjects will follow time-restricted eating of a low energy dense diet

Usual diet

Subjects will be required to follow time-restricted eating and receive the usual diet.

Group Type: ACTIVE_COMPARATOR

Usual diet

Intervention Type: BEHAVIORAL

Subjects will follow time-restricted eating of the usual diet

Interventions

Low-energy dense diet

Subjects will follow time-restricted eating of a low energy dense diet

Intervention Type: BEHAVIORAL

Usual diet

Subjects will follow time-restricted eating of the usual diet

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Candida Rebello

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Candida Rebello

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Other Identifiers

PBRC-2023-049

Identifier Type: -

Identifier Source: org_study_id