ObesityNCT04916730
Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults
A study testing Time Restricted Eating in people with Obesity, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Time Restricted Eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2020to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 26Show fewer
- 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
- 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).
- History of obstructive sleep apnea (not on stable positive pressure therapy or other treatment for at least 3 months prior to enrollment)
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Altman Clinical and Translational Research Institute
La Jolla, California, 92093
About this study
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).
Read the 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
- Obesity
- Being tested
- Standard of Care, Time Restricted Eating
- Keywords
- Key words provided by Michael Wilkinson, MD, University of California San Diego:, Catecholamine Sensitivity, Circadian Rhythm, Fasting, Obesity, Time Restricted Eating, Weight Loss
- Medical subject headings
- Obesity, Fasting, Intermittent Fasting, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareBehavioural
Participants in this arm will receive nutritional counseling from the study dietician but will not be required to adopt a 10-hr eating window.
Time Restricted EatingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Time Restricted Eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of TRE on Body Weight
Measured as change in weight (kg).
Measured: Baseline to end of 12 week intervention
Secondary outcomes (1)
Effects of TRE on Body Composition
Measured as change in percent body fat.
Measured: Baseline to end of 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start17 Dec 2020
- Primary completion26 May 2023
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Salk Institute for Biological Studies
- Responsible party
- Principal investigator, Michael Wilkinson, University of California, San Diego
- Investigators
- Michael J Wilkinson, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916730
- Sponsor's protocol ID
- 201076
- Status last verified
- Sep 2025
- First submitted
- 30 Apr 2021
- Last updated
- 19 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilkinson MJ, Padilla E, Wang Y, Raygani S, Manoogian ENC, Laing K, Tong K, Liu L, Van D, Nguyen J, Saltiel AR, Reilly SM, O'Neal M, Panda S, Majithia AR, Taub PR. Time-Restricted Eating Promotes Weight Loss and Favorable Changes in Adipose in Obesity: The TREAD Randomized Control Trial. Obesity (Silver Spring). 2026 Jul;34(7):1395-1408. doi: 10.1002/oby.70228. Epub 2026 Jun 2.
PubMed 42229885
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Time-restricted Eating on Catecholamine-sensitivity of Adipose Tissue in Obese Adults
- ClinicalTrials.gov ID
- NCT04916730
- Acronym / sponsor ID
- 201076
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Salk Institute for Biological Studies
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 7 Jun 2021 (actual)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Placebo comparator | Behavioral: Standard of CareParticipants will receive standard of care nutritional behavioral counseling and will be required to log their caloric intake through the use of a smartphone app. |
| TRE + SOC | Experimental | Behavioral: Time Restricted EatingParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard 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. | Behavioural | Standard of Care (SOC) |
| Time 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. | Behavioural | TRE + SOC |
Primary outcome
Effects of TRE on Body Weight
Time frame: Baseline to end of 12 week intervention
Measured as change in weight (kg).
1 secondary outcome
Effects of TRE on Body Composition
Time frame: Baseline to end of 12 week intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42229885Wilkinson MJ, Padilla E, Wang Y, Raygani S, Manoogian ENC, Laing K, Tong K, Liu L, Van D, Nguyen J, Saltiel AR, Reilly SM, O'Neal M, Panda S, Majithia AR, Taub PR. Time-Restricted Eating Promotes Weight Loss and Favorable Changes in Adipose in Obesity: The TREAD Randomized Control Trial. Obesity (Silver Spring). 2026 Jul;34(7):1395-1408. doi: 10.1002/oby.70228. Epub 2026 Jun 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Wilkinson, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating in people with Obesity, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of TRE on Body Weight (time frame: Baseline to end of 12 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04916730, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.