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Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study

INTRODUCTION: The aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes. METHODS AND ANALYSIS: The REStricted Eating Time (RESET) study is a randomised c...

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Autores principales: Quist, Jonas S, Jensen, Marie M, Clemmensen, Kim K B, Pedersen, Hanne, Bjerre, Natasja, Størling, Joachim, Blond, Martin B, Wewer Albrechtsen, Nicolai J, Holst, Jens J, Torekov, Signe S, Vistisen, Dorte, Jørgensen, Marit E, Panda, Satchidananda, Brock, Christina, Finlayson, Graham, Færch, Kristine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7451453/
https://www.ncbi.nlm.nih.gov/pubmed/32847912
http://dx.doi.org/10.1136/bmjopen-2020-037166
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author Quist, Jonas S
Jensen, Marie M
Clemmensen, Kim K B
Pedersen, Hanne
Bjerre, Natasja
Størling, Joachim
Blond, Martin B
Wewer Albrechtsen, Nicolai J
Holst, Jens J
Torekov, Signe S
Vistisen, Dorte
Jørgensen, Marit E
Panda, Satchidananda
Brock, Christina
Finlayson, Graham
Færch, Kristine
author_facet Quist, Jonas S
Jensen, Marie M
Clemmensen, Kim K B
Pedersen, Hanne
Bjerre, Natasja
Størling, Joachim
Blond, Martin B
Wewer Albrechtsen, Nicolai J
Holst, Jens J
Torekov, Signe S
Vistisen, Dorte
Jørgensen, Marit E
Panda, Satchidananda
Brock, Christina
Finlayson, Graham
Færch, Kristine
author_sort Quist, Jonas S
collection PubMed
description INTRODUCTION: The aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes. METHODS AND ANALYSIS: The REStricted Eating Time (RESET) study is a randomised controlled parallel-group open-label trial. 100 women and men with (1) overweight (body mass index (BMI)≥25 kg/m(2)) and prediabetes (glycated haemoglobin 39–47 mmol/mol); or (2) obesity (BMI≥30 kg/m(2)) will be randomised to a control group (habitual living) or TRE (self-selected 10-hours eating window within the period from 06:00 to 20:00 in a 1:1 ratio. Testing is scheduled at baseline and after 6 weeks (mid-intervention), 3 months (post-intervention) and 6 months (follow-up). The primary outcome is change in body weight after 3 months of intervention. Secondary outcomes include changes in body composition; measures of glucose metabolism including glycaemic variability, hormones and metabolites; subjective and metabolic markers of appetite, food preferences and reward; dietary intake; physical activity, sleep, chronotype; gastric emptying, gastrointestinal transit time and motility; respiratory and glycolytic capacities; the plasma proteome and metabolome; blood pressure, resting heart rate and heart rate variability; and resting energy expenditure and substrate oxidation. Motivation and feasibility will be examined based on interviews at baseline and after 3 months. After the 3-month intervention, a 3-month follow-up period and subsequent testing are scheduled to assess maintenance and longer-term effects. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the Capital Region of Denmark (H-18059188) and the Danish Data Protection Agency. The study will be conducted in accordance with the Declaration of Helsinki. Results from the study will address whether TRE is effective and feasible in improving health outcomes in individuals at risk of lifestyle-related diseases and can potentially inform the design of feasible health recommendations. TRIAL REGISTRATION NUMBER: NCT03854656.
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spelling pubmed-74514532020-09-02 Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study Quist, Jonas S Jensen, Marie M Clemmensen, Kim K B Pedersen, Hanne Bjerre, Natasja Størling, Joachim Blond, Martin B Wewer Albrechtsen, Nicolai J Holst, Jens J Torekov, Signe S Vistisen, Dorte Jørgensen, Marit E Panda, Satchidananda Brock, Christina Finlayson, Graham Færch, Kristine BMJ Open Diabetes and Endocrinology INTRODUCTION: The aim of this study is to investigate the effects of time-restricted eating (TRE) on change in body weight and describe changes in behaviour and metabolism in individuals at high risk of type 2 diabetes. METHODS AND ANALYSIS: The REStricted Eating Time (RESET) study is a randomised controlled parallel-group open-label trial. 100 women and men with (1) overweight (body mass index (BMI)≥25 kg/m(2)) and prediabetes (glycated haemoglobin 39–47 mmol/mol); or (2) obesity (BMI≥30 kg/m(2)) will be randomised to a control group (habitual living) or TRE (self-selected 10-hours eating window within the period from 06:00 to 20:00 in a 1:1 ratio. Testing is scheduled at baseline and after 6 weeks (mid-intervention), 3 months (post-intervention) and 6 months (follow-up). The primary outcome is change in body weight after 3 months of intervention. Secondary outcomes include changes in body composition; measures of glucose metabolism including glycaemic variability, hormones and metabolites; subjective and metabolic markers of appetite, food preferences and reward; dietary intake; physical activity, sleep, chronotype; gastric emptying, gastrointestinal transit time and motility; respiratory and glycolytic capacities; the plasma proteome and metabolome; blood pressure, resting heart rate and heart rate variability; and resting energy expenditure and substrate oxidation. Motivation and feasibility will be examined based on interviews at baseline and after 3 months. After the 3-month intervention, a 3-month follow-up period and subsequent testing are scheduled to assess maintenance and longer-term effects. ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee of the Capital Region of Denmark (H-18059188) and the Danish Data Protection Agency. The study will be conducted in accordance with the Declaration of Helsinki. Results from the study will address whether TRE is effective and feasible in improving health outcomes in individuals at risk of lifestyle-related diseases and can potentially inform the design of feasible health recommendations. TRIAL REGISTRATION NUMBER: NCT03854656. BMJ Publishing Group 2020-08-26 /pmc/articles/PMC7451453/ /pubmed/32847912 http://dx.doi.org/10.1136/bmjopen-2020-037166 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Diabetes and Endocrinology
Quist, Jonas S
Jensen, Marie M
Clemmensen, Kim K B
Pedersen, Hanne
Bjerre, Natasja
Størling, Joachim
Blond, Martin B
Wewer Albrechtsen, Nicolai J
Holst, Jens J
Torekov, Signe S
Vistisen, Dorte
Jørgensen, Marit E
Panda, Satchidananda
Brock, Christina
Finlayson, Graham
Færch, Kristine
Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study
title Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study
title_full Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study
title_fullStr Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study
title_full_unstemmed Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study
title_short Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study
title_sort protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the restricted eating time (reset) study
topic Diabetes and Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7451453/
https://www.ncbi.nlm.nih.gov/pubmed/32847912
http://dx.doi.org/10.1136/bmjopen-2020-037166
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