Clinical trial NCT06259435: Modulating Energy Density in Time-Restricted Eating
Official title: Modulating Energy Density in Time-Restricted Eating
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insulin Resistance
Body Weight
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assigned to receive a diet low in energy density or the usual diet.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Brain Insulin Resistance
timeFrame: 8 weeks
measure: Ketones
timeFrame: 8 weeks
measure: Body weight
timeFrame: 8 weeks
measure: Peripheral insulin resistance
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Candida Rebello
role: PRINCIPAL_INVESTIGATOR
References: