NCT04916730Active, not recruiting
Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 61 (actual)
- First submitted
- 30 Apr 2021
- Start date
- 17 Dec 2020
- Primary completion date
- 26 May 2023
- Lead sponsor
- University of California, San Diego
- Diseases
- Obesity
- NCT number
- NCT04916730
What you commit to
- Study type: Interventional
- Participants enrolled: 61
- From 17 Dec 2020 to the primary completion date, 26 May 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking insulin or anti-diabetic medications within the last 6 months.
- Currently taking any medication that is meant for, or has known effect on, appetite or body weight
- History of obstructive sleep apnea (not on stable positive pressure therapy or other treatment for at least 3 months prior to enrollment)
Other illness
- Taking therapeutic anticoagulation which might increase risk of bleeding from adipose tissue biopsy
- History of surgical intervention for weight loss.
- History of eating disorder
- 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
- History of major adverse cardiovascular events (acute coronary syndrome (ACS), percutaneous coronary intervention, coronary artery bypass graft surgery, stroke/transient ischemic attack (TIA)).
- History of atrial fibrillation or atrial flutter
- History of malignancy, other than non-melanoma skin cancer, that is currently being treated, or that has not been treated with definitive therapy and considered to be in remission.
- History of hypo- or hyperthyroidism requiring dose titration of thyroid replacement medication(s) within the past 3 months (i.e. hypothyroidism on a stable dose of thyroid replacement therapy is not an exclusion)
- History of adrenal disease
- History of cirrhosis
- History of stage 4 or 5 chronic kidney disease or requiring dialysis
- History of HIV/AIDS
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
Lab values
- Manifest diabetes, defined as fasting glucose ≥ 126 mg/dL, HbA1c ≥ 6.5%, or diagnosis of diabetes.
- Abnormal screening labs: renal dysfunction (eGFR \< 30 ml/min/1.73 m2), anemia, hypo- or hyperthyroidism, coagulopathy, abnormal liver function (AST, ALT \> 3x upper limit of normal)
Other
- 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.
- Currently enrolled in a weight-loss or weight-management program
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Altman Clinical and Translational Research Institute Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
Related publications
- Time-Restricted Eating Promotes Weight Loss and Favorable Changes in Adipose in Obesity: The TREAD Randomized Control Trial.Obesity (Silver Spring) · 2026 · PMID 42229885
This page is information, not medical advice. Discuss any trial with your doctor.