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| Name | Class |
|---|---|
| Salk Institute for Biological Studies | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effects of TRE on Body Weight | Measured as change in weight (kg). | Baseline to end of 12 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of TRE on Body Composition | Measured as change in percent body fat. | Baseline to end of 12 week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Effects of TRE on Inflammation in Obese Adipose Tissue (Exploratory Outcome) | Measured as inflammatory marker mRNA. | Baseline to end of 12 weeks |
| Effects of TRE on Catecholamine Sensitivity of Obese Adipose Tissue (Exploratory Outcome) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael J Wilkinson, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altman Clinical and Translational Research Institute | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42229885 | Derived | 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. |
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Out of 85 potential participants screened for study eligibility, 61 met the inclusion criteria and were subsequently randomized to treatment. One participant was excluded from analysis because of an underlying muscular dystrophy known to affect body composition.
Participants were recruited based on physician referral at a single academic center between November 2020 and February 2023. The first potential participant screened for study eligibility was on December 3, 2020 (enrolled (randomized) December 17, 2020) and the last participant screened for eligibility was in February 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care (SOC) | 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. 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. |
| FG001 | TRE + SOC | 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 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care (SOC) | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Effects of TRE on Body Weight | Measured as change in weight (kg). | Intent to treat population (all participants assigned to Standard of Care (SOC) or TRE + SOC). | Posted | Mean | 95% Confidence Interval | Kg | Baseline to end of 12 week intervention |
|
14 weeks
Throughout the intervention, we monitored participants for any potential adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care (SOC) | 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael J. Wilkinson, MD | University of California, San Diego | (858)246-2510 | mjwilkinson@health.ucsd.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 29, 2024 | Aug 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D005215 | Fasting |
| D000093763 | Intermittent Fasting |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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. |
|
Measured as release of free fatty acids (uM).
| Baseline to end of 12 week intervention |
| Physician Decision |
|
| BG001 |
| TRE + SOC |
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 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg^m2 |
|
| Body Weight | Mean | Standard Deviation | Kg |
|
|
|
|
| Secondary | Effects of TRE on Body Composition | Measured as change in percent body fat. | Posted | Mean | 95% Confidence Interval | percentage of body fat | Baseline to end of 12 week intervention |
|
|
|
| Other Pre-specified | Effects of TRE on Inflammation in Obese Adipose Tissue (Exploratory Outcome) | Measured as inflammatory marker mRNA. | These experiments could not be conducted as planned because of budgetary constraints. | Posted | Count of Participants | Participants | Baseline to end of 12 weeks |
|
|
| Other Pre-specified | Effects of TRE on Catecholamine Sensitivity of Obese Adipose Tissue (Exploratory Outcome) | Measured as release of free fatty acids (uM). | These experiments were not technically feasible with human adipose tissue | Posted | Count of Participants | Participants | Baseline to end of 12 week intervention |
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | TRE + SOC | 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 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. | 0 | 30 | 0 | 30 | 0 | 30 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D001836 | Body Weight Changes |