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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

TypeNameDescription
BEHAVIORALStandard of CareParticipants in this arm will receive nutritional counseling from the study dietician but will not be required to adopt a 10-hr eating window.
BEHAVIORALTime Restricted EatingParticipants 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.