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Completed

NCT Number: NCT06259435

Modulating Energy Density in Time-Restricted Eating

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

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Low-energy dense diet

Behavioral

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

Usual diet

Behavioral

Subjects will follow time-restricted eating of the usual diet

Primary outcomes

  1. Brain Insulin Resistance

    Time frame: 8 weeks

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

  2. Ketones

    Time frame: 8 weeks

    Ketones

  3. Body weight

    Time frame: 8 weeks

    Body weight

  4. Peripheral insulin resistance

    Time frame: 8 weeks

    Homeostasis model assessment of insulin resistance (HOMA-IR)

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: MEDITRE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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