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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
69
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
University of Copenhagen
Frederiksberg, Denmark
Centre for Nutrition Research, University of Navarra
Pamplona, Navarre, Spain
University of Liverpool
Liverpool, United Kingdom
Blood glucose area under the curve (AUC)
Area Under the Curve (AUC) for blood glucose (120 min post-intake)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Blood Insulin AUC
Area Under the Curve for blood Insulin (120 min post-intake)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Hunger iAUC
Incremental Area Under the Curve for hunger (120 min post-intake)
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting Blood glucose
Fasting blood glucose
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min Blood glucose
Blood glucose at 30 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min Blood glucose
Blood glucose at 60 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min Blood glucose
Blood glucose at 90 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min Blood glucose
Blood glucose at 120 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting Blood insulin
Fasting blood insulin
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min Blood insulin
Blood insulin at 30 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min Blood insulin
Blood insulin at 60 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min Blood insulin
Blood insulin at 90 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min Blood insulin
Blood insulin at 120 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting Hunger (VAS registered)
Fasting subjective appetite questionnaire. Visual Analogue Scale
Time frame: Clinical Investigation Day 1, 2, 3, 4
5 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 5 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
15 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 15 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 30 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
45 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 45 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 60 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 120 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
180 min Hunger (VAS registered)
Subjective appetite questionnaire. Visual Analogue Scale at 180 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting Blood cholesterol
Fasting blood cholesterol
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min Blood cholesterol
Blood cholesterol at 30 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min Blood cholesterol
Blood cholesterol at 60 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min Blood cholesterol
Blood cholesterol at 90 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min Blood cholesterol
Blood cholesterol at 120 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting Triglycerides
Fasting triglycerides in serum
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min Triglycerides
Triglycerides in serum at 30 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min Triglycerides
Triglycerides in serum at 60 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min Triglycerides
Triglycerides in serum at 90 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min Triglycerides
Triglycerides in serum at 120 in post-intake
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Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting HDL-cholesterol
Fasting HDL-cholesterol in serum
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min HDL-cholesterol
HDL-cholesterol in serum at 30 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min HDL-cholesterol
HDL-cholesterol in serum at 60 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min HDL-cholesterol
HDL-cholesterol in serum at 90 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min HDL-cholesterol
HDL-cholesterol in serum at 120 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting LDL-cholesterol
Fasting LDL-cholesterol in serum
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min LDL-cholesterol
LDL-cholesterol in serum at 30 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min LDL-cholesterol
LDL-cholesterol in serum at 60 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min LDL-cholesterol
LDL-cholesterol in serum at 90 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min LDL-cholesterol
LDL-cholesterol in serum at 120 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting Alanine aminotransferase (ALT)
Fasting liver function marker ALT
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min Alanine aminotransferase (ALT)
Liver function marker ALT at 120 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting Aspartate aminotransferase (AST)
Fasting liver function marker AST
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min Aspartate aminotransferase (AST)
Liver function marker AST at 120 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
Weight
Anthropometry marker
Time frame: Visit 0 (screening), Clinical Investigation Day 4
Height
Anthropometry marker
Time frame: Visit 0 (screening)
Body Mass Index (BMI)
Anthropometry marker
Time frame: Visit 0 (screening), Clinical Investigation Day 4
Waist Circumference (WC)
Anthropometry marker
Time frame: Visit 0 (screening)
Hip Circumference (HC)
Anthropometry marker
Time frame: Visit 0 (screening)
Waist-to-hip ratio (WHR)
Anthropometry marker
Time frame: Visit 0 (screening)
Leeds Food Preference Questionnaire (LFPQ)
Change in food preference and food reward at 15-20 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
Liking (VAS registered)
Liking and explicit wanting of the beverage at 5 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
Fasting FG21
Fasting FG21 concentration in serum
Time frame: Clinical Investigation Day 1, 2, 3, 4
30 min FG21
FG21 concentration in serum at 30 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
60 min FG21
FG21 concentration in serum at 60 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
90 min FG21
FG21 concentration in serum at 90 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4
120 min FG21
FG21 concentration in serum at 120 min post-intake
Time frame: Clinical Investigation Day 1, 2, 3, 4