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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- Gibbons et al_BMJ Open_2022_Vol 12(12)_e063903_(Protocol)
Final published version, 1.17 MB, PDF document
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.
|Number of pages||9|
|Publication status||Published - 2022|
© 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.
- General endocrinology, Nutrition & dietetics, Protocols & guidelines, Public health, Sweeteners, Sweetness enhancers, Appetite, Overweight, Obesity