NCT04483180

Work Package 2 Phase 1 - Beverages Study

Sweeteners and Sweetness Enhancers: Short-term Impact on Food Behaviour, Physiology & Health (Phase 1)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Within the SWEET project (EU funded), in Work Package 2 there are two phases, this study refers to Phase 1 of the SWEET WP2 project, which will be a coordinated trial across 3 intervention centres, University of Navarra (UNAV), University of Liverpool (ULIV) and University of Copenhagen (UCPH). It will involve an acute intervention in 120 individuals to explore initial acceptance, safety and post-prandial effects of 3 S\&SE blends delivered in beverage format. The main endpoints of the SWEET WP2 Phase 1 study will be glycaemic and lipaemic responses; eating behavior (subjective appetite, food preference, cravings, reward), and health effects (rebound hunger, G.I. side effects and metabolic effects). This phase will be exploratory and will not involve any specific primary hypotheses.

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 and neuro-behavioural processes involved in satiety, consumer preference and health, and to explore mechanistic processes, genetic background, safety issues and consumer perspectives. There are 4 products being tested in 4 different formulations (sucrose-sweetened beverage control vs. 3 reformulated beverages with S\&SE). Each product will be tested at 3 intervention sites in double-blind cross-over trials with 40 subjects per site, tested per product. Therefore a total of 120 subjects will take part across the 3 intervention sites (UNAV, ULIV, UCPH). Using identical procedures each trial will consist of 4 Clinical Investigation Days (CIDs) scheduled 7-11 days apart for each of the 3 product formulations. The total duration of WP2 Phase 2 per site is 6 months, including a minimum of 22 days and a maximum of 34 days for each participant.

Conditions

• Glycemic Index
• Overweight and Obesity

Interventions

Type	Name	Description
OTHER	Comparison of sweetener blends in liquid form (cross-over study)	The aim is to compare the effects of different sweetener blends on glycemia, subjective appetite parameters and safety parameters when consumed in a beverage as part of a breakfast

Timeline

• Start date: 2020-08-14
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2020-07-23
• Last updated: 2022-08-22

Locations

3 sites across 3 countries: Denmark, Spain, United Kingdom