Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial.

BACKGROUND: Prior studies have shown that intermittent fasting is capable of producing improvements in body weight and fasted health markers. However, the extent to which intermittent fasting incurs compensatory changes in the components of energy balance and its impact on postprandial metabolism are yet to be ascertained.

METHODS: A total of 30-36 lean participants and 30-36 overweight/obese participants will be recruited to provide two separate study groups who will undergo the same protocol. Following an initial assessment of basic anthropometry and key health markers, measurements of habitual energy intake (weighed food and fluid intake) and physical activity energy expenditure (combined heart rate and accelerometry) will be obtained over 4 weeks under conditions of energy balance. Participants will then be randomly allocated to one of three experimental conditions for 20 days, namely (1) daily calorie restriction (reduce habitual daily energy intake by 25%), (2) intermittent fasting with calorie restriction (alternate between 24-hour periods of fasting and feeding to 150% of habitual daily energy intake), (3) intermittent fasting without calorie restriction (alternate between 24-hour periods of fasting and feeding to 200% of habitual daily energy intake). In addition to continued monitoring of energy intake and physical activity during the intervention, participants will report for laboratory-based assessments of various metabolic parameters both before and after the intervention. Specifically, fasting and postprandial measurements of resting metabolic rate, substrate oxidation, appetite, food preference, and plasma concentrations of key metabolites and hormones will be made, in addition to subcutaneous abdominal adipose tissue biopsies in the fasted state and an assessment of body composition via dual-energy x-ray absorptiometry.

DISCUSSION: Comparing observed changes in these measures across the three intervention arms in each group will establish the impact of intermittent fasting on postprandial metabolism and the components of energy balance in both lean and overweight/obese populations. Furthermore, this will be benchmarked against current nutritional interventions for weight management and the relative contributions of negative energy balance and fasting-dependent mechanisms in inducing any observed effects will be elucidated.

TRIAL REGISTRATION: Trial retrospectively registered at clinicaltrials.gov under reference number NCT02498002 (version: IMF-02, date: July 6, 2015).