NCT07189234

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
31mo left

Started Oct 2025

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Oct 2025Jan 2029

First Submitted

Initial submission to the registry

September 4, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 23, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

October 23, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2029

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

September 4, 2025

Last Update Submit

January 29, 2026

Conditions

Metabolic SyndromePre-diabetes

Keywords

Time Restricted EatingFasting

Outcome Measures

Primary Outcomes (1)

  • Change in Glucose Levels

    Assessed via HbA1c (%)

    54 weeks

Secondary Outcomes (6)

  • Change in glycemic variability

    54 weeks

  • Change in direct LDL-C

    54 weeks

  • Change in bone density

    54 weeks

  • Change in insulin sensitivity

    54 weeks

  • Changes in muscle mass

    54 weeks

  • +1 more secondary outcomes

Study Arms (2)

Time-restricted eating (TRE)

EXPERIMENTAL

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

Standard of care (SOC)

PLACEBO COMPARATOR

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

Standard of CareBEHAVIORAL

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

Standard of care (SOC)
Time-restricted eating (TRE) + Standard of CareBEHAVIORAL

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.

Time-restricted eating (TRE)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altman Clinical and Translational Research Institute

La Jolla, California, 92093, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35732151BACKGROUND

MeSH Terms

Conditions

Metabolic SyndromeGlucose IntoleranceIntermittent FastingFasting

Interventions

TrehalaseStandard of Care

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperglycemiaFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

DisaccharidasesGlycoside HydrolasesHydrolasesEnzymesEnzymes and CoenzymesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Pam Taub, MD

    UC San Diego Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gavin McLaren

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

September 4, 2025

First Posted

September 23, 2025

Study Start

October 23, 2025

Primary Completion (Estimated)

July 6, 2028

Study Completion (Estimated)

January 6, 2029

Last Updated

February 2, 2026

Record last verified: 2026-01

Locations

US(1)