Modulating Energy Density in Time-Restricted Eating

Insulin Resistance Clinical Trial

— MEDITRE  

Official title:

Modulating Energy Density in Time-Restricted Eating

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259435
• Other study ID #: PBRC-2023-049
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2024
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Pennington Biomedical Research Center
• Contact: Candida J Rebello, Ph.D.
• Phone: 2252882411
• Email: Candida.Rebello[@]pbrc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Body Weight
• Insulin Resistance

Intervention

Behavioral:
• Low-energy dense diet
Subjects will follow time-restricted eating of a low energy dense diet
• Usual diet
Subjects will follow time-restricted eating of the usual diet

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Insulin Resistance	Phosphorylation of serine 312 on insulin receptor substrate 1 in plasma neural-derived exosomes	8 weeks
Primary	Ketones	Ketones	8 weeks
Primary	Body weight	Body weight	8 weeks
Primary	Peripheral insulin resistance	Homeostasis model assessment of insulin resistance (HOMA-IR)	8 weeks