Long-term effects of time-restricted eating on cardiometabolic health
TIMET 2.0 - Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
This 54-week study will test if limiting daily eating to an 8–12 hour window helps adults with metabolic syndrome and pre-diabetes improve blood sugar, cholesterol, blood pressure, and body composition.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Locations | 1 site (La Jolla, California) |
| Trial ID | NCT07189234 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with metabolic syndrome and HbA1c 5.7–7.0 who currently eat for 12 hours or more per day and own a smartphone.
Not a fit: People without metabolic syndrome, those with more advanced diabetes (HbA1c above 7.0), individuals unwilling or unable to use a smartphone or wear monitoring devices, or those who cannot restrict their eating window are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this low-cost behavioral approach could improve glucose control, lipids, blood pressure, and body composition without new medications.
How similar studies have performed: Short-term and small trials of time-restricted eating have shown improvements in weight and metabolic markers, but long-term randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
La Jolla, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.