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

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT07189234
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metabolic Syndrome
  • Pre-diabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Time-restricted eating (TRE) + Standard of Care — BEHAVIORAL
    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 Care — BEHAVIORAL
    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 Details

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).

Key Dates

Start date
Oct 23, 2025
Status verified
Jan 2026
Primary completion
Jul 6, 2028
Completion
Jan 6, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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.

Primary Outcome Measure

Change in Glucose Levels [ Time Frame: 54 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Altman Clinical and Translational Research InstituteLa JollaCalifornia92093
Gavin McLaren
[email protected]
(858) 246-2342
Pam Taub, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in La Jolla, CA

By research site
Altman Clinical and Translational Research Institute· La Jolla, CA

Related Studies