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).
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 to metabolic diseases including obesity and type 2 diabetes. Conversely, maintaining a daily rhythm of feeding and fasting cycles sustains a robust circadian rhythm which improves cellular bioenergetics and results in improved metabolism. Time-restricted eating (TRE) is a specific feeding-fasting pattern in which feeding is restricted to 8-12 hours a day. Over the 54-week duration of the study, participants will be required to use a smartphone application (myCircadianClock, developed by the Salk Institute) to log all food and beverage intake. Investigators will measure height, weight, waist circumference, and blood pressure throughout the study. Blood tests will be done after an overnight fast to check HbA1C, glucose, insulin, lipids, and an NMR lipoprotein profile. Blood sugar will also be monitored continuously using a continuous glucose monitor (CGM) worn for 2 weeks at the beginning of the study, at 6 months, and at 12 months (end of the study). At these same three timepoints, participants will also wear a wrist-worn actigraphy device (actiwatch) to track physical activity and sleep patterns. Body composition will be measured using a dual energy X-ray absorptiometry (DEXA) scan, and an oral glucose tolerance test (OGTT) will be performed to assess how the body responds to sugar.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
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.
Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt the 10-hour eating window.
Altman Clinical and Translational Research Institute
La Jolla, California, United States
RECRUITINGChange in Glucose Levels
Assessed via HbA1c (%)
Time frame: 54 weeks
Change in glycemic variability
Measured by continuous glucose monitor (CGM)
Time frame: 54 weeks
Change in direct LDL-C
LDL cholesterol (mg/dl)
Time frame: 54 weeks
Change in bone density
Bone density measured by DEXA scan (g/cm\^2)
Time frame: 54 weeks
Change in insulin sensitivity
Measured by oral glucose tolerance test (OGTT)
Time frame: 54 weeks
Changes in muscle mass
Muscle mass measured by DEXA scan (kg)
Time frame: 54 weeks
Change in body fat
Measured by body fat percentage via DEXA scan (%)
Time frame: 54 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.