Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK118278-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Salk Institute for Biological Studies | OTHER |
Not provided
Not provided
Not provided
Not provided
In a randomized controlled trial, the investigators intend to measure the health impact of TRE in patients with metabolic syndrome (with three or more of the following criteria: increased waist circumference, abnormal cholesterol levels, elevated blood pressure, or elevated blood sugar), who habitually eat for more than 14 hours every day. Patients will be randomly assigned to a control group of behavioral nutrition counseling (standard of care) or the intervention group of behavioral nutrition counseling with the addition of adopting a 8-10 hour eating window for 12 weeks (TRE).
Circadian rhythms optimize nutrient homeostasis by orchestrating catabolic and anabolic metabolism to appropriate times of the 24 hour day. Chronic circadian rhythm disruption predisposes individuals to metabolic diseases including obesity and type 2 diabetes. Conversely, maintaining a daily rhythm of feeding and fasting cycles sustains a robust circadian rhythm which improves cellular bioenergetics and results in improved metabolism. Time-restricted eating (TRE) is a specific feeding-fasting pattern in which feeding is restricted to 8-12 hours a day.
At the beginning and end of the study (which will be three months in duration), the following parameters will be measured: height, weight, body mass index, percent body fat, waist/hip circumference and blood pressure. Blood sugar levels will be monitored continuously for 2 weeks at a time at the beginning and end of the study using a continuous glucose monitor. Additionally, a dual energy X-ray absorptiometry (DXA) scan will be used to collect information about body composition. Information will be collected about the mitochondria with a muscle biopsy. Participants will use a smartphone application (called myCircadianClock (mCC), developed by the Salk Institute) to keep track of food/beverage intake and will wear a wrist-worn actigraphy device to monitor physical activity levels and sleep.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOC (Standard of Care) | Placebo Comparator | Everyone in this arm 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 | Everyone in this arm will receive standard of care nutritional behavioral counseling and will implement a daily 8-10-hour window within which they must consume their 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 |
|---|---|---|---|---|
| Time Restricted Eating + Standard of Care | Behavioral | Participants in this arm will adhere to a daily, consistent 8-10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glucose levels assessed via HbA1c | HbA1c (%) | Baseline and 14 weeks |
| Change in glycemic parameters | Glycemic parameters assessed via fasting glucose (mg/dL), HOMA-IR, Insulin (mIU/L), and continuous glucose monitors (CGM). | Baseline and 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in LDL particle number | LDL particle number (nmol/L) via NMR lipoprofile | Baseline and 14 weeks |
| Change in LDL cholesterol | LDL cholesterol (mg/dl) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mitochondrial structure and gene expression in skeletal muscle | Mitochondrial structure and gene expression in skeletal muscle as assessed by skeletal muscle biopsies. | Baseline and 14 weeks |
Inclusion Criteria:
Age 18-75 years
41 ≥ BMI ≥ 25 AND
Metabolic syndrome, as defined as presence of 3 or more of the following criteria:
Elevated fasting plasma glucose ≥ 100 mg/dL and/or HbA1c ≥ 5.7% < 7.1% Elevated waist circumference: In Asians: ≥ 90 cm in men, ≥ 80 cm in women, all other races: ≥ 102 cm in men, ≥ 88 cm in women Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides Reduced High-density lipoprotein (HDL)-cholesterol < 40 mg/dL in males or < 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol Elevated blood pressure, Systolic blood pressure ≥ 135 mm Hg and/or diastolic blood pressure ≥ 85 mm Hg or drug treatment for hypertension
Own a smartphone (Apple iOS or Android OS)
Baseline eating period ≥ 12 hour window
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, anti-diabetes drugs), no dose adjustments will be allowed during the study period.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pam Taub, MD | Associate Professor of Medicine | 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 |
|---|---|---|---|
| 39348690 | Derived | Manoogian ENC, Wilkinson MJ, O'Neal M, Laing K, Nguyen J, Van D, Rosander A, Pazargadi A, Gutierrez NR, Fleischer JG, Golshan S, Panda S, Taub PR. Time-Restricted Eating in Adults With Metabolic Syndrome : A Randomized Controlled Trial. Ann Intern Med. 2024 Nov;177(11):1462-1470. doi: 10.7326/M24-0859. Epub 2024 Oct 1. | |
| 35732151 | Derived | Taub PR, Panda S. Time for better time-restricted eating trials to lessen the burden of metabolic diseases. Cell Rep Med. 2022 Jun 21;3(6):100665. doi: 10.1016/j.xcrm.2022.100665. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 4, 2024 | |
| Reset | Dec 23, 2024 | |
| Release | May 6, 2026 | |
| Reset | May 8, 2026 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Dec 2, 2021 | Apr 3, 2023 | Prot_ICF_000.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 4, 2024 | Dec 23, 2024 | |||
| May 6, 2026 |
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D018149 | Glucose Intolerance |
| D000093763 | Intermittent Fasting |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care | Behavioral | Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 8-10-hr eating window. |
|
| Baseline and 14 weeks |
| Change in HDL cholesterol | HDL cholesterol (mg/dl) | Baseline and 14 weeks |
| Change in Triglycerides | Triglycerides (mg/dl) | Baseline and 14 weeks |
| Change in body composition by DXA | Lower abdominal fat mass as assessed by dual-energy X-ray absorptiometry (DXA). | Baseline and 14 weeks |
| Change in hs-CRP | High sensitivity C-reactive protein (mg/L) | Baseline and 14 weeks |
| May 8, 2026 |
| Jul 7, 2026 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D006943 | Hyperglycemia |
| D005247 | Feeding Behavior |
| D001519 | Behavior |