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

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

Research output: Contribution to journalArticle

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).
LanguageEnglish
Pages1-11
Number of pages11
JournalTrials
Volume19
Issue number86
DOIs
StatusPublished - 2 Feb 2018

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Fasting
Randomized Controlled Trials
Energy Intake
Health
Energy Metabolism
Abdominal Subcutaneous Fat
Accelerometry
Food Preferences
Basal Metabolism
Anthropometry
Appetite
Body Composition
Eating
Heart Rate
Body Weight
X-Rays
Hormones
Biopsy
Weights and Measures
Population

Cite this

Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial. / Templeman, Iain; Thompson, Dylan; Gonzalez, Javier; Walhin, Jean-Philippe; Reeves, Sue; Rogers, Peter; Brunstrom, Jeffrey; Karagounis, Leonidas; Tsintzas, Kostas; Betts, James.

In: Trials, Vol. 19, No. 86, 02.02.2018, p. 1-11.

Research output: Contribution to journalArticle

Templeman, Iain ; Thompson, Dylan ; Gonzalez, Javier ; Walhin, Jean-Philippe ; Reeves, Sue ; Rogers, Peter ; Brunstrom, Jeffrey ; Karagounis, Leonidas ; Tsintzas, Kostas ; Betts, James. / Intermittent fasting, energy balance and associated health outcomes in adults: study protocol for a randomised controlled trial. In: Trials. 2018 ; Vol. 19, No. 86. pp. 1-11.
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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

AU - Brunstrom, Jeffrey

AU - Karagounis, Leonidas

AU - Tsintzas, Kostas

AU - Betts, James

PY - 2018/2/2

Y1 - 2018/2/2

N2 - BackgroundPrior 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.MethodsA 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.DiscussionComparing 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 registrationTrial retrospectively registered at clinicaltrials.gov under reference number NCT02498002 (version: IMF-02, date: July 6, 2015).

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

U2 - 10.1186/s13063-018-2451-8

DO - 10.1186/s13063-018-2451-8

M3 - Article

VL - 19

SP - 1

EP - 11

JO - Trials

T2 - Trials

JF - Trials

SN - 1745-6215

IS - 86

ER -