Acute and repeated impact of sweeteners and sweetness enhancers in solid and semi-solid foods on appetite: protocol for a multicentre, cross-over, RCT in people with overweight/obesity – the SWEET Project

Gibbons, C and O'Hara, B and O’Connor, D and Hardman, C and Wilton, M and Harrold, JA and Almiron-Roig, E and Navas-Carretero, S and Hodgkins, CE and Nazare, JA and Alligier, M and Martínez, JA and Scott, C and Kjølbæk, L and Normand, M and Rannou, C and Blaak, EE and Feskens, E and Moshoyiannis, H and Raben, A and Halford, JCG and Beaulieu, K and Finlayson, G (2022) Acute and repeated impact of sweeteners and sweetness enhancers in solid and semi-solid foods on appetite: protocol for a multicentre, cross-over, RCT in people with overweight/obesity – the SWEET Project. BMJ Open, 12 (12). pp. 1-8. ISSN 2044-6055 DOI: https://doi.org/10.1136/bmjopen-2022-063903

Abstract

Introduction Intake of free sugars in European countries is high and attempts to reduce sugar intake have been mostly ineffective. Non-nutritive sweeteners and sweetness enhancers (S&SEs) can maintain sweet taste in the absence of energy, but little is known about the impact of acute and repeated consumption of S&SE in foods on appetite. This study aims to evaluate the effect of acute and repeated consumption of two individual S&SEs and two S&SE blends in semisolid and solid foods on appetite and related behavioural, metabolic and health outcomes.

Methods and analysis A work package of the SWEET Project; this study consists of five double-blind randomised cross-over trials which will be carried out at five sites across four European countries, aiming to have n=213. Five food matrices will be tested across three formulations (sucrose-sweetened control vs two reformulated products with S&SE blends and no added sugar). Participants (body mass index 25–35 kg/m2; aged 18–60 years) will consume each formulation for 14 days. The primary endpoint is composite appetite score (hunger, inverse of fullness, desire to eat and prospective food consumption) over a 3-hour postprandial incremental area under the curve during clinical investigation days on days 1 and 14.

Ethics and dissemination The trial has been approved by national ethical committees and will be conducted in accordance with the Declaration of Helsinki. Results will be published in international peer-reviewed open-access scientific journals. Research data from the trial will be deposited in an open-access online research data archive.

Trial registration number NCT04633681.

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Divisions:	School of Health
Identification Number:	https://doi.org/10.1136/bmjopen-2022-063903
Status:	Published
Refereed:	Yes
Publisher:	BMJ
Additional Information:	© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use.
Uncontrolled Keywords:	General endocrinology; NUTRITION & DIETETICS; PUBLIC HEALTH; Protocols & guidelines; Humans; Sweetening Agents; Appetite; Overweight; Taste; Energy Intake; Obesity; Sugars; Randomized Controlled Trials as Topic; Multicenter Studies as Topic; 1103 Clinical Sciences; 1117 Public Health and Health Services; 1199 Other Medical and Health Sciences; 32 Biomedical and clinical sciences; 42 Health sciences; 52 Psychology
SWORD Depositor:	Symplectic
Depositing User (symplectic)	Deposited by O'Hara, Beverley
Date Deposited:	07 May 2025 12:18
Last Modified:	29 May 2025 23:41
Item Type:	Article

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Acute and repeated impact of sweeteners and sweetness enhancers in solid and semi-solid foods on appetite: protocol for a multicentre, cross-over, RCT in people with overweight/obesity – the SWEET Project

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