Cargando…
Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project
INTRODUCTION: The aim of this randomised controlled trial (RCT) is to investigate whether prolonged consumption of sweeteners and sweetness enhancers (S&SEs) within a healthy diet will improve weight loss maintenance and obesity-related risk factors and affect safety markers compared with sugar....
Autores principales: | , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9562305/ https://www.ncbi.nlm.nih.gov/pubmed/36223962 http://dx.doi.org/10.1136/bmjopen-2022-061075 |
_version_ | 1784808142394097664 |
---|---|
author | Kjølbæk, Louise Manios, Yannis Blaak, Ellen E Martínez, J. Alfredo Feskens, Edith J M Finlayson, Graham Andersen, Sabina S H Reppas, Kyriakos Navas-Carretero, Santiago Adam, Tanja C Hodgkins, Charo E del Álamo, Marta Lam, Tony Moshoyiannis, Hariklia Halford, Jason C G Harrold, Joanne A Raben, Anne |
author_facet | Kjølbæk, Louise Manios, Yannis Blaak, Ellen E Martínez, J. Alfredo Feskens, Edith J M Finlayson, Graham Andersen, Sabina S H Reppas, Kyriakos Navas-Carretero, Santiago Adam, Tanja C Hodgkins, Charo E del Álamo, Marta Lam, Tony Moshoyiannis, Hariklia Halford, Jason C G Harrold, Joanne A Raben, Anne |
author_sort | Kjølbæk, Louise |
collection | PubMed |
description | INTRODUCTION: The aim of this randomised controlled trial (RCT) is to investigate whether prolonged consumption of sweeteners and sweetness enhancers (S&SEs) within a healthy diet will improve weight loss maintenance and obesity-related risk factors and affect safety markers compared with sugar. METHODS AND ANALYSIS: SWEET (S&SEs: prolonged effects on health, obesity and safety) is a 1-year multicentre RCT including at least 330 adults with overweight (18–65 years, body mass index (BMI) >25 kg/m(2)) and 40 children (6–12 years, BMI-for-age >85th percentile). In an initial 2-month period, adults will consume a low-energy diet with the aim to achieve ≥5% weight loss. Children are advised to consume a generally healthy diet to maintain body weight, thus reducing their BMI-for-age z-score. In the following 10 months, participants will be randomised to follow a healthy ad libitum diet with or without S&SE products. Clinical investigations are scheduled at baseline, after 2, 6 and 12 months. The primary outcomes are body weight for efficacy and gut microbiota composition (in relation to metabolic health) for safety, both in adults. Secondary outcomes include anthropometry, risk markers for type-2 diabetes and cardiovascular diseases, questionnaires including, for example, food preferences, craving and appetite and tests for allergenicity. ETHICS AND DISSEMINATION: The trial protocol has been approved by the following national ethical committees; The research ethics committees of the capital region (Denmark), approval code: H-19040679, The medical ethics committee of the University Hospital Maastricht and Maastricht University (the Netherlands), approval code: NL70977.068.19/METC19-056s, Research Ethics Committee of the University of Navarra (Spain), approval code: 2019.146 mod1, Research Ethics Committee of Harokopio University (Greece), approval code: 1810/18-06-2019. The trial will be conducted in accordance with the Declaration of Helsinki. Results will be published in international peer-reviewed scientific journals regardless of whether the findings are positive, negative or inconclusive. TRIAL REGISTRATION NUMBER: NCT04226911 (Clinicaltrials.gov) |
format | Online Article Text |
id | pubmed-9562305 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-95623052022-10-15 Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project Kjølbæk, Louise Manios, Yannis Blaak, Ellen E Martínez, J. Alfredo Feskens, Edith J M Finlayson, Graham Andersen, Sabina S H Reppas, Kyriakos Navas-Carretero, Santiago Adam, Tanja C Hodgkins, Charo E del Álamo, Marta Lam, Tony Moshoyiannis, Hariklia Halford, Jason C G Harrold, Joanne A Raben, Anne BMJ Open Nutrition and Metabolism INTRODUCTION: The aim of this randomised controlled trial (RCT) is to investigate whether prolonged consumption of sweeteners and sweetness enhancers (S&SEs) within a healthy diet will improve weight loss maintenance and obesity-related risk factors and affect safety markers compared with sugar. METHODS AND ANALYSIS: SWEET (S&SEs: prolonged effects on health, obesity and safety) is a 1-year multicentre RCT including at least 330 adults with overweight (18–65 years, body mass index (BMI) >25 kg/m(2)) and 40 children (6–12 years, BMI-for-age >85th percentile). In an initial 2-month period, adults will consume a low-energy diet with the aim to achieve ≥5% weight loss. Children are advised to consume a generally healthy diet to maintain body weight, thus reducing their BMI-for-age z-score. In the following 10 months, participants will be randomised to follow a healthy ad libitum diet with or without S&SE products. Clinical investigations are scheduled at baseline, after 2, 6 and 12 months. The primary outcomes are body weight for efficacy and gut microbiota composition (in relation to metabolic health) for safety, both in adults. Secondary outcomes include anthropometry, risk markers for type-2 diabetes and cardiovascular diseases, questionnaires including, for example, food preferences, craving and appetite and tests for allergenicity. ETHICS AND DISSEMINATION: The trial protocol has been approved by the following national ethical committees; The research ethics committees of the capital region (Denmark), approval code: H-19040679, The medical ethics committee of the University Hospital Maastricht and Maastricht University (the Netherlands), approval code: NL70977.068.19/METC19-056s, Research Ethics Committee of the University of Navarra (Spain), approval code: 2019.146 mod1, Research Ethics Committee of Harokopio University (Greece), approval code: 1810/18-06-2019. The trial will be conducted in accordance with the Declaration of Helsinki. Results will be published in international peer-reviewed scientific journals regardless of whether the findings are positive, negative or inconclusive. TRIAL REGISTRATION NUMBER: NCT04226911 (Clinicaltrials.gov) BMJ Publishing Group 2022-10-12 /pmc/articles/PMC9562305/ /pubmed/36223962 http://dx.doi.org/10.1136/bmjopen-2022-061075 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://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/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Nutrition and Metabolism Kjølbæk, Louise Manios, Yannis Blaak, Ellen E Martínez, J. Alfredo Feskens, Edith J M Finlayson, Graham Andersen, Sabina S H Reppas, Kyriakos Navas-Carretero, Santiago Adam, Tanja C Hodgkins, Charo E del Álamo, Marta Lam, Tony Moshoyiannis, Hariklia Halford, Jason C G Harrold, Joanne A Raben, Anne Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project |
title | Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project |
title_full | Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project |
title_fullStr | Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project |
title_full_unstemmed | Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project |
title_short | Protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the SWEET project |
title_sort | protocol for a multicentre, parallel, randomised, controlled trial on the effect of sweeteners and sweetness enhancers on health, obesity and safety in overweight adults and children: the sweet project |
topic | Nutrition and Metabolism |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9562305/ https://www.ncbi.nlm.nih.gov/pubmed/36223962 http://dx.doi.org/10.1136/bmjopen-2022-061075 |
work_keys_str_mv | AT kjølbæklouise protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT maniosyannis protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT blaakellene protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT martinezjalfredo protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT feskensedithjm protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT finlaysongraham protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT andersensabinash protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT reppaskyriakos protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT navascarreterosantiago protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT adamtanjac protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT hodgkinscharoe protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT delalamomarta protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT lamtony protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT moshoyiannishariklia protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT halfordjasoncg protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT harroldjoannea protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject AT rabenanne protocolforamulticentreparallelrandomisedcontrolledtrialontheeffectofsweetenersandsweetnessenhancersonhealthobesityandsafetyinoverweightadultsandchildrenthesweetproject |