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

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).

SUBMITTER: Templeman I

PROVIDER: S-EPMC5797418 | biostudies-literature | 2018 Feb

REPOSITORIES: biostudies-literature

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

Templeman Iain I Thompson Dylan D Gonzalez Javier J Walhin Jean-Philippe JP Reeves Sue S Rogers Peter J PJ Brunstrom Jeffrey M JM Karagounis Leonidas G LG Tsintzas Kostas K Betts James A JA

Trials 20180202 1

<h4>Background</h4>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.<h4>Methods</h4>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 sa ...[more]

PMID: 29394908

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Project description:Background/objectivesAlternate day fasting (ADF) is a subtype of intermittent fasting and is defined as a continuous sequence of a fast day (100% energy restriction, zero calories) and a feed day (ad libitum food consumption), resulting in roughly 36-h fasting periods. Previous studies demonstrated weight reductions and improvements of cardiovascular risk factors with ADF in obese subjects. However, rigorous data on potential endocrine, metabolic and cardiovascular effects, besides weight loss, are lacking. Therefore we aim to investigate the short- and mid- to long-term clinical and molecular effects of ADF in healthy non-obese subjects.MethodsWe will perform a prospective cohort study with an embedded randomized controlled trial (RCT) including 90 healthy subjects. Thirty of them will have performed ADF for at least 6 months (mid-term group). Sixty healthy subjects without a particular diet before enrolment will serve as the control group. These subjects will be 1:1 randomized to either continuing their current diet or performing ADF for 4 weeks. All subjects will undergo study procedures that will be repeated in RCT participants after 4 weeks. These procedures will include assessment of outcome parameters, dual-energy X-ray absorptiometry, measurement of endothelial function, an oral glucose tolerance test, 24-h blood pressure measurement, retinal vessel analysis, echocardiography and physical activity measurement by an accelerometer. Blood, sputum, buccal mucosa and faeces will be collected for laboratory analyses. Participants in the RCT will wear a continuous glucose monitor to verify adherence to the study intervention.Planned outcomesThe aim of this project is to investigate the effects of ADF on human physiology and molecular cellular processes. This investigation should gain in-depth mechanistic insights into the concept of ADF and form the basis for larger subsequent cohort recruitment and consecutive intervention studies.Trial registrationNCT02673515; registered 24 November 2015. Current protocol date/version: 7 February 2017/version 1.8.

Project description:BackgroundOverweight and obesity among adults are a growing global public health threat and an essential risk factor for various noncommunicable diseases. Although intermittent fasting is a generally new dietary approach to weight management that has been increasingly practiced worldwide, the effectiveness of 2 days per week dry fasting remains unclear.ObjectiveThe Cardiometabolic and Anthropometric Outcomes of Intermittent Fasting study aims to determine the cardiometabolic, anthropometric, dietary intake, and quality of life changes among civil servants with overweight and obesity, following combined intermittent fasting and healthy plate (IFHP) and healthy plate (HP) and explore the participants' experiences.MethodsWe designed a mixed methods quasi-experimental study to evaluate the effectiveness of the IFHP and HP methods among adults with overweight and obesity. A total of 177 participants were recruited for this study, of which 91 (51.4%) were allocated to the IFHP group and 86 (48.6%) to the HP group. The intervention comprised 2 phases: supervised (12 weeks) and unsupervised (12 weeks). Data collection was conducted at baseline, after the supervised phase (week 12), and after the unsupervised phase (week 24). Serum and whole blood samples were collected from each participant for analysis. Data on sociodemographic factors, quality of life, physical activity, and dietary intake were also obtained using questionnaires during data collection.ResultsMost of the participants were female (147/177, 83.1%) and Malay (141/177, 79.7%). The expected outcomes of this study are changes in body weight, body composition, quality of life, physical activity, dietary intake, and cardiometabolic parameters such as fasting blood glucose, 2-hour postprandial blood glucose, hemoglobin A1c, fasting insulin, and lipid profile.ConclusionsThe Cardiometabolic and Anthropometric Outcomes of Intermittent Fasting study is a mixed methods study to evaluate the effectiveness of combined IFHP and HP interventions on cardiometabolic and anthropometric parameters and explore participants' experiences throughout the study.Trial registrationClinicalTrials.gov NCT05034653; https://clinicaltrials.gov/ct2/show/NCT05034653.International registered report identifier (irrid)RR1-10.2196/33801.

Project description:BackgroundPopular beliefs that breakfast is the most important meal of the day are grounded in cross-sectional observations that link breakfast to health, the causal nature of which remains to be explored under real-life conditions.ObjectiveThe aim was to conduct a randomized controlled trial examining causal links between breakfast habits and all components of energy balance in free-living humans.DesignThe Bath Breakfast Project is a randomized controlled trial with repeated-measures at baseline and follow-up in a cohort in southwest England aged 21-60 y with dual-energy X-ray absorptiometry-derived fat mass indexes ≤11 kg/m² in women (n = 21) and ≤7.5 kg/m² in men (n = 12). Components of energy balance (resting metabolic rate, physical activity thermogenesis, energy intake) and 24-h glycemic responses were measured under free-living conditions with random allocation to daily breakfast (≥700 kcal before 1100) or extended fasting (0 kcal until 1200) for 6 wk, with baseline and follow-up measures of health markers (eg, hematology/biopsies).ResultsContrary to popular belief, there was no metabolic adaptation to breakfast (eg, resting metabolic rate stable within 11 kcal/d), with limited subsequent suppression of appetite (energy intake remained 539 kcal/d greater than after fasting; 95% CI: 157, 920 kcal/d). Rather, physical activity thermogenesis was markedly higher with breakfast than with fasting (442 kcal/d; 95% CI: 34, 851 kcal/d). Body mass and adiposity did not differ between treatments at baseline or follow-up and neither did adipose tissue glucose uptake or systemic indexes of cardiovascular health. Continuously measured glycemia was more variable during the afternoon and evening with fasting than with breakfast by the final week of the intervention (CV: 3.9%; 95% CI: 0.1%, 7.8%).ConclusionsDaily breakfast is causally linked to higher physical activity thermogenesis in lean adults, with greater overall dietary energy intake but no change in resting metabolism. Cardiovascular health indexes were unaffected by either of the treatments, but breakfast maintained more stable afternoon and evening glycemia than did fasting.

Project description:IntroductionPrescription charges prevent many people from accessing the medicines they need to maintain or improve their health. In New Zealand, where most people pay $5 per prescription item, Māori and Pacific peoples, those living in most deprived areas and those with chronic health conditions are the most likely to report that cost prevents them from accessing medicines.Methods and analysisThis randomised controlled trial (RCT) will evaluate the effect of removing prescription charges on health outcomes and healthcare utilisation patterns of people with low income and high health needs. We will enrol 2000 participants: half will be allocated to the intervention group and we will pay for their prescription charges for 12 months. The other half will receive usual care. The primary outcome will be hospital bed-days. Secondary outcomes will be: all-cause and diabetes/mental health-specific hospitalisations, prescription medicines dispensed (number and type), deaths, emergency department visits and quality of life as measured by the 5-level EQ-5D version. Costs associated with these outcomes will be compared in an economic substudy. A qualitative substudy will also help understand the impact of free prescriptions on participant well-being using in-depth interviews.DiscussionBeing unable to afford prescription medicines is only one of many factors that influence adherence to medicines, but removing prescription charges is relatively simple and in New Zealand would be cheap compared with other policy changes. This RCT will help identify the extent of the impact of a simple intervention to improve access to medicines on health outcomes and health service utilisation.Ethics and disseminationThis study was approved by the Central Health and Disability Ethics Committee (NZ) in July 2019 (19/CEN/33). Findings will be reported in peer-reviewed publications, as well as in professional newsletters, mainstream media and through public meetings.Trial registration numberACTRN12618001486213p.

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

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