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Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial.
Trials. 2018 Feb 02; 19(1):86.T

Abstract

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).

Authors+Show Affiliations

Department for Health, University of Bath, Bath, BA2 7AY, UK. i.s.templeman@bath.ac.uk.Department for Health, University of Bath, Bath, BA2 7AY, UK.Department for Health, University of Bath, Bath, BA2 7AY, UK.Department for Health, University of Bath, Bath, BA2 7AY, UK.Department of Life Sciences, University of Roehampton, London, SW15 4JD, UK.School of Experimental Psychology, University of Bristol, Bristol, BS8 1TU, UK.School of Experimental Psychology, University of Bristol, Bristol, BS8 1TU, UK.Faculty of Sport and Health Sciences, University of St Mark and St John, Plymouth, PL6 8BH, UK.School of Life Sciences, University of Nottingham, Queen's Medical Centre, Nottingham, NG7 2UH, UK.Department for Health, University of Bath, Bath, BA2 7AY, UK.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

29394908

Citation

Templeman, Iain, et al. "Intermittent Fasting, Energy Balance and Associated Health Outcomes in Adults: Study Protocol for a Randomised Controlled Trial." Trials, vol. 19, no. 1, 2018, p. 86.
Templeman I, Thompson D, Gonzalez J, et al. Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial. Trials. 2018;19(1):86.
Templeman, I., Thompson, D., Gonzalez, J., Walhin, J. P., Reeves, S., Rogers, P. J., Brunstrom, J. M., Karagounis, L. G., Tsintzas, K., & Betts, J. A. (2018). Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial. Trials, 19(1), 86. https://doi.org/10.1186/s13063-018-2451-8
Templeman I, et al. Intermittent Fasting, Energy Balance and Associated Health Outcomes in Adults: Study Protocol for a Randomised Controlled Trial. Trials. 2018 Feb 2;19(1):86. PubMed PMID: 29394908.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial. AU - Templeman,Iain, AU - Thompson,Dylan, AU - Gonzalez,Javier, AU - Walhin,Jean-Philippe, AU - Reeves,Sue, AU - Rogers,Peter J, AU - Brunstrom,Jeffrey M, AU - Karagounis,Leonidas G, AU - Tsintzas,Kostas, AU - Betts,James A, Y1 - 2018/02/02/ PY - 2017/11/09/received PY - 2018/01/04/accepted PY - 2018/2/4/entrez PY - 2018/2/6/pubmed PY - 2019/3/15/medline KW - Body composition KW - Calorie restriction KW - Energy balance KW - Intermittent fasting KW - Metabolism KW - Obesity KW - Physical activity KW - Postprandial SP - 86 EP - 86 JF - Trials JO - Trials VL - 19 IS - 1 N2 - 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). SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29394908/Intermittent_fasting_energy_balance_and_associated_health_outcomes_in_adults:_study_protocol_for_a_randomised_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2451-8 DB - PRIME DP - Unbound Medicine ER -