NCT04633681

Impact of Sweeteners on Behaviour, Physiology & Health

Acute and Repeated Impact of Sweeteners and Sweetness Enhancers on Food Behaviour, Physiology & Health (SWEET Work Package 2 Phase 2)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: University of Leeds · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the acute (1-day) and repeated (2-week) effects of combinations of Sweeteners \& Sweetness Enhancer blends on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preferences and health.

Detailed description

This protocol has the overall objective to evaluate the acute (short-term, 1 day) and repeated (medium-term, 2 week) effects of combinations of sweeteners and sweetness enhancers (S\&SEs) on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preference and health, and to explore mechanistic processes, genetic background, safety issues and consumer perspectives. There are 5 products being tested in 3 different formulations (sucrose-sweetened control vs 2 reformulated with S\&SE). Each product will be tested at 2 intervention sites in double-blind cross-over trials with 48 subjects (24 per site) tested per product. Therefore a total of 240 subjects will take part across the 5 intervention sites (Navarra, Leeds, Liverpool, Copenhagen, Lyon). Using identical procedures each trial will consist of 2 Clinical Investigation Days (CIDs) scheduled 12 days apart for each of the 3 product formulations. A 2-week wash-out period will be given between formulations. The total duration of WP2 Phase 2 is 12 months, including a 5-month duration for each cross-over trial.

Conditions

• Eating Behavior

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Sweetener and sweetness enhancer consumption	Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.

Timeline

• Start date: 2021-04-01
• Primary completion: 2023-09-29
• Completion: 2023-11-20
• First posted: 2020-11-18
• Last updated: 2024-08-12

Locations

5 sites across 4 countries: Denmark, France, Spain, United Kingdom