Recruiting
Phase 2

Time Restricted Eating

Sponsor:

UCLA

Code:

NCT07189234

Conditions

Metabolic Syndrome

Pre-diabetes

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Time-restricted eating (TRE) + Standard of Care

Standard of Care

Study Details

Brief summary:

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).

Conditions

Metabolic Syndrome

Pre-diabetes

Study ID

NCT07189234

Start date

Oct 23, 2025

Status verified date

Jan, 2026

Completion date

Jan 6, 2029

Anticipated

Primary completion date

Jul 6, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion criteria:

1. Age: 18-75 years
2. HbA1c: 5.7% to 7.0%
3. Metabolic syndrome (must meet 3 criteria):

1. Elevated systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg OR an antihypertensive therapy)
2. 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
3. Fasting plasma triglycerides ≥ 150 mg/dL, or on drug treatment for elevated triglycerides d) Reduced High-density lipoprotein (HDL)- cholesterol < 40 mg/dL in males or < 50 mg//dL in females, or drug treatment for reduced HDL-cholesterol e) Fasting glucose ≥ 100 mg/dL
4. Own a smartphone (Apple iOS or Android OS)
5. Baseline eating period ≥12 hour/day
6. Patients on a stable dose of cardiovascular medications (HMG CoA reductase inhibitors \[statins\]), other lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), or anti-hypertensive drugs) for at least 1 month are allowed.
7. Patients on GLP-1 R agonists, SGLT2 inhibitors, or Metformin must be on stable doses for at least 3 months.

Exclusion criteria:

1. Use of sulfonylurea or insulin.
2. HbA1C > 7.0%
3. Pregnant or breastfeeding. Anyone of reproductive age will receive pregnancy test prior to DXA scan.
4. Caregiver for a dependent requiring frequent nocturnal care / sleep interruptions.
5. Shift workers with variable (e.g. nocturnal) hours.
6. Frequent travel to different time zones during the study period.
7. Active tobacco use or illicit drug use or history of treatment for alcohol abuse.
8. History of major adverse cardiovascular event within the past year (acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft surgery, hospitalization for congestive heart failure, stroke/transient ischemic attack).
9. History of surgical intervention for weight management within the past 2 years, or longer if deemed unsafe following review by medical investigators
10. Uncontrolled arrhythmia (i.e. rate -controlled atrial fibrillation / atrial flutter are not exclusion criteria)
11. History of thyroid disease 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).
12. History of adrenal disease.
13. History of malignancy undergoing active treatment, except non-melanoma skin cancer.
14. Known history of type 1 diabetes.
15. History of an eating disorder.
16. History of cirrhosis.
17. History of stage 4 or 5 chronic kidney disease or requiring dialysis.
18. Currently enrolled in a weight-loss or weight-management program.
19. On a special or prescribed diet for other reasons (e.g. Celiac disease).
20. Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
21. Inability or unwillingness to utilize the mCC app throughout study duration.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Time-restricted eating (TRE)

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.

placebo comparator: Standard of care (SOC)

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.

Interventions

Time-restricted eating (TRE) + 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.

Standard of Care

Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt the 10-hour eating window.

Primary outcome measure

  • Change in Glucose Levels [ Time Frame: 54 weeks ]

Central Contacts and Locations

Locations

Altman Clinical and Translational Research Institute

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Pam Taub, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Keywords

  • Time Restricted Eating
  • Fasting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-02-02.