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
| Autor: | Louise Kjølbæk, Yannis Manios, Ellen E Blaak, J. Alfredo Martínez, Edith J M Feskens, Graham Finlayson, Sabina S H Andersen, Kyriakos Reppas, Santiago Navas-Carretero, Tanja C Adam, Charo E Hodgkins, Marta del Álamo, Tony Lam, Hariklia Moshoyiannis, Jason C G Halford, Joanne A Harrold, Anne Raben |
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| Přispěvatelé: | Humane Biologie, RS: NUTRIM - R1 - Obesity, diabetes and cardiovascular health, Nutrition and Movement Sciences |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Adult
Global Nutrition MICROBIOLOGY Wereldvoeding Allergy DIABETES & ENDOCRINOLOGY Body Weight General Medicine Overweight Overweight/complications Sweetening Agents Weight Loss Humans Multicenter Studies as Topic Obesity Obesity/complications Child Sugars Randomized Controlled Trials as Topic VLAG Nutrition |
| Zdroj: | BMJ Open 12 (2022) 10 Kjølbæk, L, Manios, Y, Blaak, E E, Martínez, J A, Feskens, E J M, Finlayson, G, Andersen, S S H, Reppas, K, Navas-Carretero, S, Adam, T C, Hodgkins, C E, Álamo, M D, Lam, T, Moshoyiannis, H, Halford, J C G, Harrold, J A & Raben, A 2022, ' 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 ', BMJ Open, vol. 12, no. 10, e061075 . https://doi.org/10.1136/bmjopen-2022-061075 BMJ Open, 12(10):e061075. BMJ Publishing Group BMJ Open, 12(10) |
| ISSN: | 2044-6055 1904-0679 |
| Popis: | IntroductionThe 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 analysisSWEET (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/m2) 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 disseminationThe 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 numberNCT04226911(Clinicaltrials.gov) |
| Databáze: | OpenAIRE |
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