Trials / Active Not Recruiting
Active Not RecruitingNCT04916730
Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- University of California, San Diego · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In a randomized controlled trial, the investigators intend to measure the health impact of time-restricted eating (TRE) in obese patients (body mass index (BMI) ≥ 30 kg/m2), who habitually eat for more than 14 hours every day. Patients will be randomly assigned to a control group of behavioral nutritional counseling (standard of care) or the intervention group of behavioral nutrition counseling with the addition of adopting a 10-hour eating window for 12 weeks (TRE).
Detailed description
The current worldwide epidemic of obesity puts millions of people at increased risk for cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM), and while insulin resistance has been a traditional focus of treatment, resistance to catecholamines in obesity is likely a key factor hampering weight loss efforts. Catecholamines are key drivers of lipolysis in adipose tissue and bind to beta-3 adrenergic receptors (ADRB3) on the surface of adipocytes. Chronic inflammation is characteristic of obesity and suppresses the expression of adipocyte ADRB3, increasing fat storage. This leaves adipose tissue metabolically inflexible and in a state of energy preservation instead of burning fat to promote and maintain weight loss. Thus, catecholamine resistance of adipose tissue is an important target for lifestyle and therapeutic intervention. Time-restricted eating (TRE) is a therapeutic intervention that promotes weight loss and healthier metabolism by aligning dietary intake with circadian rhythms. In this RCT, individuals with obesity will be enrolled in a 14-week study of TRE and behavioral nutritional counseling vs behavioral nutritional counseling alone. In the TRE group, dietary intake will be limited to a self-selected 10-hour window. Information will be collected about adipose tissue catabolism (lipolysis) using samples collected by adipose tissue biopsy of subcutaneous abdominal adipose tissue.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Standard of Care | Participants in this arm will receive nutritional counseling from the study dietician but will not be required to adopt a 10-hr eating window. |
| BEHAVIORAL | Time Restricted Eating | Participants in this arm will adhere to a daily, consistent self-selected 10-hr eating window for the course of the study intervention period as well as receive nutritional counseling from the study dietitian. |
Timeline
- Start date
- 2020-12-17
- Primary completion
- 2023-05-26
- Completion
- 2026-01-01
- First posted
- 2021-06-07
- Last updated
- 2025-10-14
- Results posted
- 2025-10-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04916730. Inclusion in this directory is not an endorsement.