Long Term Impact of Time-Restricted Eating on Parameters of Cardiometabolic Health
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of California, San Diego
About this trial
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 criteria
Qualifiers
Age: 18-75 years
HbA1c: 5.7% to 7.0%
Elevated systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 85 mm Hg OR an antihypertensive therapy)
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Time-restricted eating (TRE) + Standard of Care
- Standard of Care
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, San Diego
Lead sponsor
Salk Institute for Biological Studies
Collaborator
Source ClinicalTrials.gov