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Metabolic SyndromePhase 2TIMET 2NCT07189234

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

A Phase 2 study of Metabolic Syndrome and Pre-diabetes, run by University of California, San Diego at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metabolic Syndrome, Pre-diabetes
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
1 siteUnited States
Study dates
23 Oct 2025to 6 Jan 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gavin McLaren contact

(858) 246-2342

preventivecvresearch@health.ucsd.edu

United States1 site, 1 recruiting

  • Altman Clinical and Translational Research Institute

    La Jolla, California, 92093

    Gavin McLaren, (858) 246-2342, preventivecvresearch@health.ucsd.edu

    Pam Taub, MD

    Recruiting

Other trials in United States

About this study

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

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).

Read the detailed description

Circadian rhythms optimize nutrient homeostasis by orchestrating catabolic and anabolic metabolism to appropriate times of the 24 hour day. Chronic circadian rhythm disruption predisposes individuals to metabolic diseases including obesity and type 2 diabetes. Conversely, maintaining a daily rhythm of feeding and fasting cycles sustains a robust circadian rhythm which improves cellular bioenergetics and results in improved metabolism. Time-restricted eating (TRE) is a specific feeding-fasting pattern in which feeding is restricted to 8-12 hours a day.

Over the 54-week duration of the study, participants will be required to use a smartphone application (myCircadianClock, developed by the Salk Institute) to log all food and beverage intake. Investigators will measure height, weight, waist circumference, and blood pressure throughout the study. Blood tests will be done after an overnight fast to check HbA1C, glucose, insulin, lipids, and an NMR lipoprotein profile. Blood sugar will also be monitored continuously using a continuous glucose monitor (CGM) worn for 2 weeks at the beginning of the study, at 6 months, and at 12 months (end of the study). At these same three timepoints, participants will also wear a wrist-worn actigraphy device (actiwatch) to track physical activity and sleep patterns. Body composition will be measured using a dual energy X-ray absorptiometry (DEXA) scan, and an oral glucose tolerance test (OGTT) will be performed to assess how the body responds to sugar.

Being tested
Time-restricted eating (TRE) + Standard of Care, Standard of Care
Keywords
Time Restricted Eating, Fasting
Medical subject headings
Metabolic Syndrome, Glucose Intolerance, Intermittent Fasting, Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Time-restricted eating (TRE) + Standard of CareBehavioural

    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.

  • Standard of CareBehavioural

    Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt the 10-hour eating window.

Study groups in NCT07189234
Study groupRoleWhat they receive
Time-restricted eating (TRE)ExperimentalParticipants in this arm will be asked to maintain their current lifestyle and medication management routines, while adhering to a daily, consistent 10-hour eating window. They will also receive standard lifestyle coaching, including meetings with a dietician to review dietary intake, and are required to track their caloric intake using a smartphone app.
Receives: Behavioral: Time-restricted eating (TRE) + Standard of Care
Standard of care (SOC)Placebo comparatorParticipants in this arm will maintain their current lifestyle and medication management without adhering to the 10-hour eating window. They will receive standard lifestyle coaching, including meetings with a dietician to review dietary intake, and will be asked to track their caloric intake using a smartphone app.
Receives: Behavioral: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Glucose Levels

    Assessed via HbA1c (%)

    Measured: 54 weeks

Secondary outcomes (6)

  1. Change in glycemic variability

    Measured by continuous glucose monitor (CGM)

    Measured: 54 weeks

  2. Change in direct LDL-C

    LDL cholesterol (mg/dl)

    Measured: 54 weeks

  3. Change in bone density

    Bone density measured by DEXA scan (g/cm^2)

    Measured: 54 weeks

  4. Change in insulin sensitivity

    Measured by oral glucose tolerance test (OGTT)

    Measured: 54 weeks

  5. Changes in muscle mass

    Muscle mass measured by DEXA scan (kg)

    Measured: 54 weeks

  6. Change in body fat

    Measured by body fat percentage via DEXA scan (%)

    Measured: 54 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2025
  2. Study start23 Oct 2025
  3. Primary completion6 Jul 2028 (estimated)
  4. Study completion6 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07189234
Sponsor's protocol ID
812281
Acronym
TIMET 2
Status last verified
Jan 2026
First submitted
4 Sep 2025
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Taub PR, Panda S. Time for better time-restricted eating trials to lessen the burden of metabolic diseases. Cell Rep Med. 2022 Jun 21;3(6):100665. doi: 10.1016/j.xcrm.2022.100665.

    PubMed 35732151

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Metabolic Syndrome and Pre-diabetes, run by University of California, San Diego at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gavin McLaren ((858) 246-2342, preventivecvresearch@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glucose Levels (time frame: 54 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07189234, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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