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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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 (required) and 2 of the following:

‣ 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

⁃ Reduced High-density lipoprotein (HDL)- cholesterol \< 40 mg/dL in males or \< 50 mg/dL in females, or drug treatment for reduced HDL-cholesterol

⁃ 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), metformin, other lipid-modifying drugs (including over-the-counter drugs such as red yeast rice and fish oil), anti-hypertensive drugs, GLP-1R agonists and SGLT2 inhibitors) for at least 3 months are allowed.

Locations
United States
California
Altman Clinical and Translational Research Institute
RECRUITING
La Jolla
Contact Information
Primary
Gavin McLaren
preventivecvresearch@health.ucsd.edu
(858) 246-2342
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2031-10-01
Participants
Target number of participants: 140
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Salk Institute for Biological Studies
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov