Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults

NCT04916730 | Active Not Recruiting Results

• 1 other identifier: 201076
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Obesity

Keywords

Key words provided by Michael Wilkinson, MD, University of California San Diego:; Catecholamine Sensitivity; Circadian Rhythm; Fasting; Obesity; Time Restricted Eating; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Effects of TRE on Body Weight

  Measured as change in weight (kg).

  Baseline to end of 12 week intervention

Secondary Outcomes (1)

• Effects of TRE on Body Composition

  Baseline to end of 12 week intervention

Other Outcomes (2)

• Effects of TRE on Inflammation in Obese Adipose Tissue (Exploratory Outcome)

  Baseline to end of 12 weeks

• Effects of TRE on Catecholamine Sensitivity of Obese Adipose Tissue (Exploratory Outcome)

  Baseline to end of 12 week intervention

Study Arms (2)

Standard of Care (SOC)

PLACEBO COMPARATOR

Participants will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app.

Behavioral: Standard of Care

TRE + SOC

EXPERIMENTAL

Participants in this arm will receive standard of care nutritional behavioral counseling and will implement a daily, self-selected, 10-hour window within which they must consume all calories. They will also be required to log their caloric intake through the use of a smartphone app

Behavioral: Time Restricted Eating

Interventions

Standard of Care BEHAVIORAL

Participants in this arm will receive nutritional counseling from the study dietician but will not be required to adopt a 10-hr eating window.

Standard of Care (SOC)

Time Restricted Eating BEHAVIORAL

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.

TRE + SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: ≥ 18 years old
• BMI 30-50 kg/m2
• Own a smartphone with Apple iOS or Android OS
• Baseline eating window ≥ 14 hours/day
• If patients are on cardiovascular medications (HMG CoA reductase inhibitors (statins), other lipid modifying drugs (including over the counter drugs such as red yeast rice and fish oil), anti-hypertensive drugs, no dose adjustments will be allowed during the study period.

You may not qualify if:

• Taking insulin or anti-diabetic medications within the last 6 months.
• Manifest diabetes, defined as fasting glucose ≥ 126 mg/dL, HbA1c ≥ 6.5%, or diagnosis of diabetes.
• Currently taking any medication that is meant for, or has known effect on, appetite or body weight
• Pregnant or breast-feeding women.
• Caregiver for a dependent requiring frequent nocturnal care/sleep interruptions. Shift workers with variable (e.g. nocturnal) hours.
• Planned international travel (time zone changes) during study period.
• Taking therapeutic anticoagulation which might increase risk of bleeding from adipose tissue biopsy
• History of surgical intervention for weight loss.
• History of eating disorder
• Currently enrolled in a weight-loss or weight-management program
• On a special or prescribed diet for other reasons (e.g. Celiac disease)
• Known inflammatory and/or rheumatologic disease
• Active tobacco abuse or illicit drug use or history of treatment for alcohol abuse
• History of bone marrow or solid organ transplant
• History of heart failure

Sponsors & Collaborators

• University of California, San Diego: lead
• Salk Institute for Biological Studies: collaborator

Study Sites (1)

Altman Clinical and Translational Research Institute

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Obesity; Fasting; Intermittent Fasting; Weight Loss

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior; Body Weight Changes

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Michael J. Wilkinson, MD
• Organization: University of California, San Diego

mjwilkinson@health.ucsd.edu

(858)246-2510

Study Officials

• Michael J Wilkinson, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: June 7, 2021
• Study Start: December 17, 2020
• Primary Completion: May 26, 2023
• Study Completion: January 1, 2026
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)