Obesity Clinical Trial
Official title:
Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight Adults
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.
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