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 cont...
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BMJ Publishing Group
2020-08-01
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| Online Access: | https://bmjopen.bmj.com/content/10/8/e037166.full |
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| author | Marit E Jørgensen Graham Finlayson Dorte Vistisen Jonas S Quist Marie M Jensen Kim K B Clemmensen Hanne Pedersen Natasja Bjerre Joachim Størling Martin B Blond Nicolai J Wewer Albrechtsen Jens J Holst Signe S Torekov Satchidananda Panda Christina Brock Kristine Færch |
| author_facet | Marit E Jørgensen Graham Finlayson Dorte Vistisen Jonas S Quist Marie M Jensen Kim K B Clemmensen Hanne Pedersen Natasja Bjerre Joachim Størling Martin B Blond Nicolai J Wewer Albrechtsen Jens J Holst Signe S Torekov Satchidananda Panda Christina Brock Kristine Færch |
| author_sort | Marit E Jørgensen |
| collection | DOAJ |
| 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/m2) and prediabetes (glycated haemoglobin 39–47 mmol/mol); or (2) obesity (BMI≥30 kg/m2) 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. |
| format | Article |
| id | doaj-art-ca44a97453f14b11b240fba08e95bc01 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-08-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-ca44a97453f14b11b240fba08e95bc012025-08-20T02:51:07ZengBMJ Publishing GroupBMJ Open2044-60552020-08-0110810.1136/bmjopen-2020-037166Protocol 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) studyMarit E Jørgensen0Graham Finlayson1Dorte Vistisen2Jonas S Quist3Marie M Jensen4Kim K B Clemmensen5Hanne Pedersen6Natasja Bjerre7Joachim Størling8Martin B Blond9Nicolai J Wewer Albrechtsen10Jens J Holst11Signe S Torekov12Satchidananda Panda13Christina Brock14Kristine Færch15National Institute of Public Health, University of Southern Denmark, Copenhagen, DenmarkSchool of Psychology, University of Leeds, Leeds, UKSteno Diabetes Center Copenhagen, Gentofte, DenmarkSteno Diabetes Center Copenhagen, Gentofte, DenmarkSteno Diabetes Center Copenhagen, Gentofte, DenmarkSteno Diabetes Center Copenhagen, Gentofte, DenmarkInternal Medicine, Zealand University Hospital Koge, Koge, DenmarkSteno Diabetes Center Copenhagen, Gentofte, DenmarkSteno Diabetes Center Copenhagen, Herlev, DenmarkSteno Diabetes Center Copenhagen, Gentofte, DenmarkDepartment of Clinical Biochemistry, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark4 Department of Biomedical Sciences, University of Copenhagen, Copenhagen, DenmarkDepartment of Biomedical Sciences, University of Copenhagen, Copenhagen, DenmarkSalk Institute for Biological Studies, La Jolla, California, USAMech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Aalborg, DenmarkSteno Diabetes Center Copenhagen, Gentofte, DenmarkIntroduction 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/m2) and prediabetes (glycated haemoglobin 39–47 mmol/mol); or (2) obesity (BMI≥30 kg/m2) 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.https://bmjopen.bmj.com/content/10/8/e037166.full |
| spellingShingle | Marit E Jørgensen Graham Finlayson Dorte Vistisen Jonas S Quist Marie M Jensen Kim K B Clemmensen Hanne Pedersen Natasja Bjerre Joachim Størling Martin B Blond Nicolai J Wewer Albrechtsen Jens J Holst Signe S Torekov Satchidananda Panda Christina Brock Kristine Færch 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 BMJ Open |
| 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 |
| url | https://bmjopen.bmj.com/content/10/8/e037166.full |
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