Body Weight Changes Clinical Trial
Official title:
A Randomized Controlled Trial to Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain in Overweight But Generally Healthy Adults Over the Winter Holiday Period
The purpose of this study is to assess the effects of repeated periods of modified fasting in support of healthy weight management and prevention of weight gain over the winter holiday period (mid-November to early January) in comparison to regular diet and activity.
This study is a randomized, placebo-controlled trial in which subjects assigned to the
modified fasting cohort will undergo consecutive weekly cycles of modified fasting for two
consecutive days.
The primary objective is to assess the effects of repeated periods of modified fasting on
body weight.
The secondary objectives include assessment of the effects of modified fasting on percent
body fat, waist circumference and fasting levels of hs-CRP (hs-C-reactive protein), IL-6
(Interleukin-6), IL-8 (interleukin-8), IL-12 (interleukin-12), TNF-a (tumor necrosis
factor-alpha), IGF-1 (insulin-like growth factor 1), IGFBP-1 (insulin-like growth
factor-binding protein 1) , Total Cholesterol, LDL cholesterol, HDL cholesterol, Glucose,
Triglyceride, Insulin, Vitamin-D, 25-Hydroxy,
Participants will undergo assessments of blood tests, vital signs, BMI, body weight, waist
circumference and percent body fat.
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