ClinicalTrials.gg
RecruitingNCT07189234TIMET 2Updated Feb 2, 2026

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

A Phase 2 interventional study of Time-restricted eating (TRE) + Standard of Care and Standard of Care in Metabolic Syndrome and Pre-diabetes, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-02.

Sponsored by University of California, San Diego · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

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.

02

Conditions studied

  • Metabolic Syndrome
  • Pre-diabetes

Keywords

  • Time Restricted Eating
  • Fasting
03

In context

Metabolic Syndrome

2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.

This study's planned enrollment of 140 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age: 18-75 years
  2. : 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

Exclusion criteria:

  1. Use of sulfonylurea or insulin.
  2. > 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/).
  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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Time-restricted eating (TRE)

    Participants 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.

    Behavioral: Time-restricted eating (TRE) + Standard of Care

  • Placebo comparator
    Standard of care (SOC)

    Participants 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.

    Behavioral: Standard of Care

Interventions

  • BehavioralTime-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.

  • BehavioralStandard 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.

06

What researchers measure

Primary outcomes

  1. Change in Glucose Levels

    Assessed via HbA1c (%)

    Time frame: 54 weeks

Secondary outcomes

  1. Change in glycemic variability

    Measured by continuous glucose monitor (CGM)

    Time frame: 54 weeks

  2. Change in direct LDL-C

    LDL cholesterol (mg/dl)

    Time frame: 54 weeks

  3. Change in bone density

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

    Time frame: 54 weeks

  4. Change in insulin sensitivity

    Measured by oral glucose tolerance test (OGTT)

    Time frame: 54 weeks

  5. Changes in muscle mass

    Muscle mass measured by DEXA scan (kg)

    Time frame: 54 weeks

  6. Change in body fat

    Measured by body fat percentage via DEXA scan (%)

    Time frame: 54 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2025 (actual). Primary completion is estimated for Jul 2028, 32 months after the start.

Of 28 non-industry phase 2 interventional studies under Metabolic Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 62. This study's planned 32 months is close to that.

Counting every sponsor, half of 31 studies reached it within 29 months; a quarter within 18 and three quarters within 58.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2025
First posted
Sep 23, 2025
StartActual
Oct 23, 2025
Primary completionEst.
Jul 6, 2028
CompletionEst.
Jan 6, 2029
Last update
Feb 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07189234
Collaborators
Salk Institute for Biological Studies
Responsible party
Pam Taub, MD (Associate Professor of Medicine, University of California, San Diego) — Principal investigator
First posted
Sep 23, 2025
Start date
Oct 23, 2025
Primary completion
Jul 6, 2028 (estimated)
Completion
Jan 6, 2029 (estimated)
Last update
Feb 2, 2026

Study contacts

Gavin McLaren
Contact
preventivecvresearch@health.ucsd.edu
(858) 246-2342
Pam Taub, MD
principal investigator · UC San Diego Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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