NCT07189234 Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
| NCT ID | NCT07189234 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Diego |
| Condition | Metabolic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-10-23 |
| Primary Completion | 2028-07-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 140 participants in total. It began in 2025-10-23 with a primary completion date of 2028-07-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Pam Taub, MD
PRINCIPAL INVESTIGATOR
UC San Diego Health
Frequently Asked Questions
Who can join the NCT07189234 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metabolic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07189234 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07189234 currently recruiting?
Yes, NCT07189234 is actively recruiting participants. Contact the research team at preventivecvresearch@health.ucsd.edu for enrollment information.
Where is the NCT07189234 trial being conducted?
This trial is being conducted at La Jolla, United States.
Who is sponsoring the NCT07189234 clinical trial?
NCT07189234 is sponsored by University of California, San Diego. The principal investigator is Pam Taub, MD at UC San Diego Health. The trial plans to enroll 140 participants.