Modulating Energy Density in Time-Restricted Eating

Not Applicable

Recruiting

• Conditions: Body Weight; Insulin Resistance
• Interventions: Behavioral: Low-energy dense diet; Behavioral: Usual diet

• Registration Number: NCT06259435
• Lead Sponsor: Pennington Biomedical Research Center

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. 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

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 Timeline

• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-02-05
• Study First Posted: 2024-02-14
• Status Verified: 2024-05
• Study Start: 2024-05-29
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low energy dense diet	Low-energy dense diet	Subjects will be required to follow time-restricted eating and receive a diet low in energy density
Usual diet	Usual diet	Subjects will be required to follow time-restricted eating and receive the usual diet.

Primary Outcome Measures

Name	Time	Method
Brain Insulin Resistance	8 weeks	Phosphorylation of serine 312 on insulin receptor substrate 1 in plasma neural-derived exosomes
Peripheral insulin resistance	8 weeks	Homeostasis model assessment of insulin resistance (HOMA-IR)
Ketones	8 weeks	Ketones
Body weight	8 weeks	Body weight

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States