Actively Recruiting
Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
Led by University of California, San Diego · Updated on 2026-02-02
140
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
S
Salk Institute for Biological Studies
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- HbA1c between 5.7% and 7.0%
- Diagnosis of metabolic syndrome with at least 3 criteria including elevated blood pressure, increased waist circumference (specific cutoffs for Asians and others), high fasting triglycerides or treatment for it, low HDL cholesterol or treatment for it, and fasting glucose 100 mg/dL
- Own a smartphone with Apple iOS or Android OS
- Habitual eating period of 12 hours or more per day
- Stable dose of cardiovascular medications such as statins or antihypertensives for at least 1 month
- Stable doses of GLP-1 receptor agonists, SGLT2 inhibitors, or Metformin for at least 3 months if applicable
You will not qualify if you...
- Use of sulfonylurea or insulin
- HbA1c greater than 7.0%
- Pregnant or breastfeeding
- Caregiver for a dependent requiring frequent night care or sleep interruptions
- Shift workers with variable hours including night shifts
- Frequent travel across time zones during the study
- Active tobacco use, illicit drug use, or history of alcohol abuse treatment
- History of major cardiovascular events within the past year
- Weight management surgery within the past 2 years or longer if considered unsafe
- Uncontrolled arrhythmia (controlled atrial fibrillation/flutter allowed)
- Recent thyroid disease needing dose changes within 3 months
- History of adrenal disease
- Active cancer treatment except for non-melanoma skin cancer
- Known type 1 diabetes
- History of eating disorders
- History of cirrhosis
- Advanced chronic kidney disease or dialysis
- Current enrollment in weight-loss programs
- Special or prescribed diet for other medical reasons
- Uncontrolled psychiatric disorders
- Unable or unwilling to use the study smartphone app for the duration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92093
Actively Recruiting
Research Team
G
Gavin McLaren
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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