Modulating Energy Density in Time-Restricted Eating

NCT06259435 | Completed

• 1 other identifier: PBRC-2023-049
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Insulin resistance and
2. 2.Body weight.
3. 3.Following time-restricted eating and given a diet reduced in energy density or
4. 4.Following time-restricted eating and given a diet typically consumed in this population

Conditions

Insulin Resistance; Body Weight

Outcome Measures

Primary Outcomes (4)

• Brain Insulin Resistance

  Phosphorylation of serine 312 on insulin receptor substrate 1 in plasma neural-derived exosomes

  8 weeks

• Ketones

  Ketones

  8 weeks

• Body weight

  Body weight

  8 weeks

• Peripheral insulin resistance

  Homeostasis model assessment of insulin resistance (HOMA-IR)

  8 weeks

Study Arms (2)

Low energy dense diet

EXPERIMENTAL

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

Behavioral: Low-energy dense diet

Usual diet

ACTIVE COMPARATOR

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

Behavioral: Usual diet

Interventions

Low-energy dense diet BEHAVIORAL

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

Low energy dense diet

Usual diet BEHAVIORAL

Subjects will follow time-restricted eating of the usual diet

Usual diet

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) ≥ 30kg/m2.
• Mini-Mental State Examination (MMSE) \> 25
• Geriatric Depression Scale-15 (GDS-15) \< 9
• Homeostatic model assessment of insulin resistance (HOMA-IR) ≥ 3.

You may not qualify if:

• Diagnosis of Type 2 diabetes received more than five years ago
• Diagnosis of type 1 diabetes
• Evidence of clinically significant renal dysfunction or disease
• History of malignancy during the past five years
• Being treated with systemic steroids, olanzapine, or clozapine
• Being treated with prescription medications for obesity
• Being treated with thiazolidinediones, glucagon-like-receptor agonists, Dipeptidyl Peptidase IV inhibitors, and insulin
• Weight change \> 3 kg in the preceding three months
• 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)

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Insulin Resistance; Body Weight

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Candida Rebello

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomly assigned to one of two groups. Except for the Director of the Metabolic Kitchen and the dietitians assigned to the study, all other researchers conducting the study will be blinded to the treatment group assignment of subjects.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Subjects will be randomly assigned to receive a diet low in energy density or the usual diet.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 14, 2024
• Study Start: May 29, 2024
• Primary Completion: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)