NCT07189234 · University of California, San Diego
Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
(TIMET 2)
What this study is about
In a randomly assigned 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.
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age: 18-75 years
- HbA1c: 5.7% to 7.0%
- Metabolic syndrome (must meet 3 criteria):
- Elevated systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg OR an antihypertensive therapy)
- 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
- 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
- Own a smartphone (Apple iOS or Android OS)
- Baseline eating period ≥12 hour/day
- 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.
- Patients on GLP-1 R agonists, SGLT2 inhibitors, or Metformin must be on stable doses for at least 3 months.
Exclusion criteria
- Use of sulfonylurea or insulin.
- HbA1C \> 7.0%
- Pregnant or breastfeeding. Anyone of reproductive age will receive pregnancy test prior to DXA scan.
- Caregiver for a dependent requiring frequent nocturnal care / sleep interruptions.
- Shift workers with variable (e.g. nocturnal) hours.
- Frequent travel to different time zones during the study period.
- Active tobacco use or illicit drug use or history of treatment for alcohol abuse.
- 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).
- History of surgical intervention for weight management within the past 2 years, or longer if deemed unsafe following review by medical investigators
- Uncontrolled arrhythmia (i.e. rate -controlled atrial fibrillation / atrial flutter are not exclusion criteria)
- 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).
- History of adrenal disease.
- History of malignancy undergoing active treatment, except non-melanoma skin cancer.
- Known history of type 1 diabetes.
- History of an eating disorder.
- History of cirrhosis.
- History of stage 4 or 5 chronic kidney disease or requiring dialysis.
- Currently enrolled in a weight-loss or weight-management program.
- On a special or prescribed diet for other reasons (e.g. Celiac disease).
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
- Inability or unwillingness to utilize the mCC app throughout study duration.
Where
- La Jolla, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 2, 2026 · Source of record for eligibility and locations