A Phase 2 interventional study of Time-restricted eating (TRE) + Standard of Care and Standard of Care in Metabolic Syndrome and Pre-diabetes, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by University of California, San Diego · Phase 2, Interventional, and Treatment
In a randomized controlled trial, the investigators intend to measure the health impact of time restricted eating (TRE) in patients with metabolic syndrome (with elevated blood pressure and at least 2 of the following: increased waist circumference, abnormal cholesterol levels, elevated triglycerides, and elevated fasting glucose levels), who habitually eat more than 12 hours every day. Patients will be randomly assigned to a control group (standard of care) or intervention group (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.
Over the 54-week duration of the study, participants will be required to use a smartphone application (myCircadianClock, developed by the Salk Institute) to log all food and beverage intake. Investigators will measure height, weight, waist circumference, and blood pressure throughout the study. Blood tests will be done after an overnight fast to check HbA1C, glucose, insulin, lipids, and an NMR lipoprotein profile. Blood sugar will also be monitored continuously using a continuous glucose monitor (CGM) worn for 2 weeks at the beginning of the study, at 6 months, and at 12 months (end of the study). At these same three timepoints, participants will also wear a wrist-worn actigraphy device (actiwatch) to track physical activity and sleep patterns. Body composition will be measured using a dual energy X-ray absorptiometry (DEXA) scan, and an oral glucose tolerance test (OGTT) will be performed to assess how the body responds to sugar.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 140 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.
Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Metabolic syndrome (must meet 3 criteria):
Elevated waist circumference:
- In Asians: ≥ 90 cm in men, ≥80 cm in women In all other races: ≥ 102 cm in men, ≥ 88 cm in women
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will be asked to maintain their current lifestyle and medication management routines, while adhering to a daily, consistent 10-hour eating window. They will also receive standard lifestyle coaching, including meetings with a dietician to review dietary intake, and are required to track their caloric intake using a smartphone app.
Behavioral: Time-restricted eating (TRE) + Standard of Care
Participants in this arm will maintain their current lifestyle and medication management without adhering to the 10-hour eating window. They will receive standard lifestyle coaching, including meetings with a dietician to review dietary intake, and will be asked to track their caloric intake using a smartphone app.
Behavioral: Standard of Care
Participants in this arm will adhere to a daily, consistent 10-hour eating window for the course of the study as well as receive nutritional counseling from the study dietician.
Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt the 10-hour eating window.
Change in Glucose Levels
Assessed via HbA1c (%)
Time frame: 54 weeks
Change in glycemic variability
Measured by continuous glucose monitor (CGM)
Time frame: 54 weeks
Change in direct LDL-C
LDL cholesterol (mg/dl)
Time frame: 54 weeks
Change in bone density
Bone density measured by DEXA scan (g/cm\^2)
Time frame: 54 weeks
Change in insulin sensitivity
Measured by oral glucose tolerance test (OGTT)
Time frame: 54 weeks
Changes in muscle mass
Muscle mass measured by DEXA scan (kg)
Time frame: 54 weeks
Change in body fat
Measured by body fat percentage via DEXA scan (%)
Time frame: 54 weeks
Started Oct 2025 (actual). Primary completion is estimated for Jul 2028, 32 months after the start.
Of 28 non-industry phase 2 interventional studies under Metabolic Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 62. This study's planned 32 months is close to that.
Counting every sponsor, half of 31 studies reached it within 29 months; a quarter within 18 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
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