Modulating Energy Density in Time-Restricted Eating (MEDITRE)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Body Weight; Insulin Resistance
• Intervention / Treatment: Behavioral: Low-energy dense diet; Behavioral: Usual diet

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Candida J Rebello, Ph.D.; Phone Number: 2252882411; Email: Candida.Rebello@pbrc.edu
• Study Contact Backup: Name: Darryl Whitehead, BS; Email: Darryl.Whitehead@pbrc.edu

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center
      • Contact: Candida Rebello, Ph.D.; Phone Number: 225-763-3159; Email: Candida.Rebello@pbrc.edu
      • Contact: Darryl Whitehead, BS; Email: Candida.Rebello@pbrc.edu
      • Principal Investigator: Candida Rebello, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low energy dense diet; Subjects will be required to follow time-restricted eating and receive a diet low in energy density	Behavioral: Low-energy dense diet; Subjects will follow time-restricted eating of a low energy dense diet
Active Comparator: Usual diet; Subjects will be required to follow time-restricted eating and receive the usual diet.	Behavioral: Usual diet; Subjects will follow time-restricted eating of the usual diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Candida Rebello, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance; Body Weight
• Other Study ID Numbers: PBRC-2023-049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No