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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
175
Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.
University of Copenhagen
Copenhagen, Denmark
CRNH-RA
Lyon, France
University of Navarra
Pamplona, Spain
University of Leeds
Leeds, West Yorkshire, United Kingdom
University of Liverpool
Composite Appetite Sensations Incremental Area Under the Curve
Incremental area under the curve (iAUC) for composite appetite sensations in response to each product. During each of the Clinical Investigation Days iAUC composite appetite will be measured 180 minutes post intake. The following sensations of appetite will be used in the composite measure: * hunger * fullness * desire to eat * prospective consumption Minimum value 0 Maximum value 100 Higher scores mean worse outcome
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Leeds Food Preference Questionnaire (LFPQ) Explicit Liking
Change in explicit liking for foods at 15 min post intake Minimum value -100 Maximum value 100 Higher scores mean worse outcome
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Leeds Food Preference Questionnaire (LFPQ) Implicit Wanting
Change in implicit wanting for foods at 15 min post intake Minimum value -100 Maximum value 100 Higher scores mean worse outcome
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Leeds Food Preference Questionnaire (LFPQ) Relative preference
Change in relative preference for foods at 15 min post intake Minimum value -48 Maximum value 48 Higher scores mean worse outcome
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Leeds Food Preference Questionnaire (LFPQ) Explicit wanting
Change in explicit wanting for foods at 15 min post intake Minimum value -100 Maximum value 100 Higher scores mean worse outcome
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Craving Control
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Liverpool, United Kingdom
Craving Control examined in a fasted state. Minimum value 0 Maximum value 100 Higher scores mean better outcome
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Craving for Sweet
Craving for Sweet examined in a fasted state. Minimum value 0 Maximum value 100 Higher scores mean worse outcome
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Craving for Savoury
Craving for Savoury examined in a fasted state. Minimum value 0 Maximum value 100 Higher scores mean worse outcome
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Control of Eating Questionnaire (CoEQ): Positive Mood
Positive Mood examined in a fasted state. Minimum value 0 Maximum value 100 Higher scores mean better outcome
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Blood Glucose Incremental Area Under the Curve
Incremental area under the curve for blood glucose concentrations in response to each product (120 min post intake).
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Blood Insulin Incremental Area Under the Curve
Incremental area under the curve for blood insulin concentrations in response to each product (120 min post intake).
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Cephalic and intestinal satiety biomarkers: Glucagon-like peptide-1 (GLP-1)
Incremental area under the curve for blood GLP-1 concentrations in response to each product (120 min post intake).
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Cephalic and intestinal satiety biomarkers: Ghrelin
Incremental area under the curve for blood Ghrelin concentrations in response to each product (120 min post intake).
Time frame: Clinical Investigation Day 1, 2, 3, 4, 5, 6