Status:
RECRUITING
Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
Lead Sponsor:
University of California, San Diego
Collaborating Sponsors:
Salk Institute for Biological Studies
Conditions:
Metabolic Syndrome
Pre-diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion Criteria:
- 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).
- Uncontrolled arrhythmia (i.e. rate -controlled atrial fibrillation / atrial flutter are not exclusion criteria)
- 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).
- 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.
- Currently enrolled in a weight-loss or weight-management program.
- On a special or prescribed diet for other reasons (e.g. Celiac disease).
- Uncontrolled psychiatric disorder (including history of hospitalization for psychiatric illness).
Exclusion
Key Trial Info
Start Date :
September 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2031
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07189234
Start Date
September 22 2025
End Date
October 1 2031
Last Update
September 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Altman Clinical and Translational Research Institute
La Jolla, California, United States, 92093