Long-term effects of time-restricted eating on cardiometabolic health

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 trial will assign adults with metabolic syndrome and pre-diabetes to either time-restricted eating (TRE) plus standard care or standard care alone for 54 weeks. Participants will log all food and beverage intake using the myCircadianClock smartphone app and will wear continuous glucose monitors and wrist actigraphy for two-week periods at baseline, 6 months, and 12 months. Investigators will collect height, weight, waist circumference, blood pressure, fasting labs (including HbA1c, glucose, insulin, lipids and an NMR lipoprotein profile), DEXA body composition scans, and oral glucose tolerance tests to track cardiometabolic changes. The study tests whether maintaining an 8–12 hour daily feeding window produces sustained improvements in metabolic risk factors compared with usual care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Altman Clinical and Translational Research Institute
  La Jolla, California, United States Recruiting

Study contacts

• Principal investigator: Pam Taub, MD — UC San Diego Health
• Study coordinator: Gavin McLaren
• Email: preventivecvresearch@health.ucsd.edu
• Phone: (858) 246-2342

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.