Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health

TIMET 2.0 - Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health

Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health (NCT07189234) is a Phase 2 interventional studying Metabolic Syndrome and Pre-diabetes, sponsored by University of California, San Diego. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Metabolic Syndrome and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 140 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Metabolic Syndrome subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BEHAVIORAL

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.

BEHAVIORAL

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Altman Clinical and Translational Research Institute

La Jolla, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07189234), the sponsor (University of California, San Diego), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07189234 clinical trial studying?

Who can participate in NCT07189234?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07189234?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07189234. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07189234. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.