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

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Title
Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial
Published in
Trials, February 2018
DOI 10.1186/s13063-018-2451-8
Pubmed ID
Authors

Iain Templeman, Dylan Thompson, Javier Gonzalez, Jean-Philippe Walhin, Sue Reeves, Peter J. Rogers, Jeffrey M. Brunstrom, Leonidas G. Karagounis, Kostas Tsintzas, James A. Betts

Abstract

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

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Geographical breakdown

Country Count As %
Unknown 318 100%

Demographic breakdown

Readers by professional status Count As %
Student > Bachelor 67 21%
Student > Master 44 14%
Researcher 16 5%
Student > Ph. D. Student 16 5%
Student > Doctoral Student 16 5%
Other 40 13%
Unknown 119 37%
Readers by discipline Count As %
Medicine and Dentistry 53 17%
Nursing and Health Professions 49 15%
Sports and Recreations 26 8%
Biochemistry, Genetics and Molecular Biology 17 5%
Agricultural and Biological Sciences 7 2%
Other 35 11%
Unknown 131 41%