Modulating Energy Density in Time-Restricted Eating (MEDITRE)

Pennington Biomedical Research Center

Status: Enrolling

Conditions: Insulin Resistance; Body Weight

Treatments: Behavioral: Usual diet; Behavioral: Low-energy dense diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06259435

PBRC-2023-049

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Low energy dense diet

Experimental group

Description:

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

Treatment:

Behavioral: Low-energy dense diet

Usual diet

Active Comparator group

Description:

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

Treatment:

Behavioral: Usual diet