Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Time-restricted feeding (TRF) is a novel type of intermittent fasting that involves eating
      within a daily period of 10 hours or less, followed by fasting for at least 14 hours daily.
      Several studies in rodents report that TRF reduces body weight, improves blood sugar control,
      and reduces the risk of cardiovascular disease-even when food intake is matched to the
      control group or no weight loss occurs. Preliminary evidence suggests that TRF may also
      increase weight loss, fat loss, and reduce the risk of diabetes and cardiovascular disease in
      humans. This study will test whether TRF enhances fat loss and increases weight loss in
      adults with obesity, relative to conventional dieting alone. In addition, this study will
      determine whether TRF reduces risk factors for type 2 diabetes and cardiovascular disease and
      will measure the feasibility and acceptability of TRF.

      In conjunction with the parent study described above, four ancillary studies will be
      conducted:

        1. Effect of weight loss on nitrogen metabolism and bacteria in the mouth. The primary
           endpoints for this ancillary study are plasma and salivary nitrate and nitrite, and the
           secondary endpoints are salivary nitrate reductase activity and salivary bacterial
           abundance.

        2. Effect of weight loss on several biomarkers related to kidney stones. The primary
           endpoint for this ancillary study is urinary oxalate, and the secondary endpoints are
           urinary citrate, chloride, sodium, potassium, calcium, phosphorus, uric acid, and
           creatinine.

        3. Effect of meal timing on blood pressure regulation and kidney function. The primary
           endpoints of this ancillary study include urinary aldosterone excretion, sodium,
           potassium, and endothelin, whereas the secondary endpoints include nitric oxide and
           albumin. Additional exploratory endpoints include renal injury markers (KIM-1, nephrin,
           and urine albumin-to-creatinine ratio), measures of reactive oxidative stress (e.g.,
           hydrogen peroxide and TBARs), and urinary exosomes. Urine will be analyzed in 12-hour
           bins to determine how meal timing affects differentially affects these endpoints during
           the daytime and nighttime. The effects of weight loss on these endpoints may also be
           considered.

        4. Validation of a meal timing questionnaire to assess the distribution of food intake
           throughout the day.
    


Intervention name(s): Early Time-Restricted Feeding; Control Schedule; Structured Weight Loss Program
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Eat all meals between 7 am - 3 pm for an average of ≥6 days per week.; Eat all meals over a 12-hour or longer period for an average of ≥6 days per week.; A structured weight loss program with physical activity recommendations and dietary counseling.
Other intervention name(s): Early TRF; eTRF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment