- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04483180
Work Package 2 Phase 1 - Beverages Study (SWEET-WP2-P1)
Sweeteners and Sweetness Enhancers: Short-term Impact on Food Behaviour, Physiology & Health (Phase 1)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Frederiksberg, Denmark
- University of Copenhagen
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Navarra
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Pamplona, Navarra, Spain, 31008
- Centre for Nutrition Research, University of Navarra
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Liverpool, United Kingdom
- University of Liverpool
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age: 18-60 years.
- BMI: 25 to 35 kg/m2.
- For women: Use of contraceptive methods or not planning to become pregnant for the duration of the study.
- Regular consumption of sugar-containing foods and willing to consume artificially-sweetened beverages (a score of ≥ 5 on the short sFFQ Part 1a and answer Yes to all questions in Part 2).
- Able to participate on the visit days/CIDs during normal working hours.
- Healthy as determined from the self-reported medical history or when a clinical condition exists, when this is considered to be irrelevant (i.e. not influencing study outcomes) for the study by the study medical doctor.
- Consuming breakfast regularly (at least 5 days per week).
- Liking of the study foods defined by a response of Yes for each of the breakfast foods during the pre-screening interview and a score of 40 % or above on the Liking VAS for the control beverage.
- Able to understand and be willing to sign the informed consent form, and to follow all the study procedures and requirements.
Exclusion Criteria:
- Blood donation < 3 month prior to study.
- Deficient nutrition or hydration status as identified from the pre-screening/screening session (i.e. absence of disease including anaemia, BMI >18 kg/m2, or other criteria as determined by the study doctor).
- Food allergy, intolerance, restriction or avoidance of any of the study foods (e.g. veganism) or history of anaphylactic reaction to any food.
- Likelihood for disordered eating defined as a score of 20 or more on the EAT-26 test.
- Currently dieting to lose weight or having been on weight cycles (i.e. repeatedly lost and re-gained weight) in the last 3 months.
- Smoking.
- Binge drinking i.e. consuming >14 units of alcohol per week in women or >21 units/week in men less than 4 days apart.
- Performing >10 h of intense physical activity per week.
- Continuous night or late shift work (ending later than 11 pm on a permanent basis). Rotational shift work allowed if can attend on days that do not follow a late/night shift.
- Self-reported use of drugs of abuse within the previous 12 months.
- For women: Pregnancy, lactation.
- Persons who do not have access to either (mobile) phone or internet (this is necessary when being contacted by the study personnel during the study).
- Insufficient communication in the national language.
- Proven or suspected inability, physically or mentally, to comply with the procedures required by the study protocol as evaluated by the daily study manager, site-PI, PI or clinical responsible. This includes volunteers for which insufficient collaboration may be foreseen.
- Subject's general condition contraindicates continuing in the study as evaluated by the daily study manager, site-PI, PI or clinical responsible.
- Simultaneous participation in other relevant clinical intervention studies.
- Previous university or college training related to eating behaviour research.
Medical conditions as known by the person:
- Self-reported eating disorders.
- Diagnosed anaemia.
- Diagnosed diabetes mellitus.
- Abnormal gastro-intestinal (G.I) function or structure such as malformation, angiodysplasia, active peptic ulcer.
- Active inflammatory bowel disease, celiac disease, chronic pancreatitis or other disorder potentially causing malabsorption.
- History of G.I. surgery with permanent effect (i.e. surgical treatment of obesity).
- Medical history of cardio-vascular disease (e.g. current angina; myocardial infarction or stroke within the past 6 months; heart failure; symptomatic peripheral vascular disease).
- Significant liver disease, e.g. cirrhosis (fatty liver disease allowed).
- Malignancy which is currently active or in remission for less than five years after last treatment (local basal and squamous cell skin cancer allowed).
- Thyroid diseases, except those on Levothyroxine treatment of hypothyroidism if the person has been on a stable dose for at least 3 months.
- Psychiatric illness (e.g. major depression, bipolar disorders).
Medication:
- Use currently or within the previous 3 months of prescription or over the counter medication that has the potential of affecting appetite, satiety or body weight incl. food supplements.
Except: low dose antidepressants if they, in the judgement of the daily study manager, site-PI, PI or clinical responsible, do not affect weight or following the study protocol. Levothyroxine for treatment of hypothyroidism is allowed if the person has been on a stable dose for at least 3 months.
• Cholesterol lowering medication, if the dose has changed during the last 3 months (i.e. the medication is allowed if the participant has been on a stable dose for at least 3 months).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Placebo Comparator: Control
Beverage containing a sucrose solution.
Same aspect and flavor than the experimental beverages.
About 1/4 of participants will start with this beverage first.
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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
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Experimental: Sucralose / acesulfame K
Beverage containing a blend of sweeteners based on sucralose and acesulfame K. Same aspect and flavour than the control beverage.
About 1/4 of participants will start with this beverage first.
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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
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Experimental: Stevia rebaudioside A / thaumatin
Beverage containing a blend of sweeteners based on stevia rebaudioside A and thaumatin.
Same aspect and flavour than the control beverage.
About 1/4 of participants will start with this beverage first.
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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
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Experimental: Mogroside V / stevia rebaudioside M
Beverage containing a blend of sweeteners based on mogroside V and stevia rebaudioside M. Same aspect and flavour than the control beverage.
About 1/4 of participants will start with this beverage first.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood glucose area under the curve (AUC)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Area Under the Curve (AUC) for blood glucose (120 min post-intake)
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Clinical Investigation Day 1, 2, 3, 4
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Blood Insulin AUC
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Area Under the Curve for blood Insulin (120 min post-intake)
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Clinical Investigation Day 1, 2, 3, 4
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Hunger iAUC
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Incremental Area Under the Curve for hunger (120 min post-intake)
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Clinical Investigation Day 1, 2, 3, 4
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Fasting Blood glucose
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Fasting blood glucose
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Clinical Investigation Day 1, 2, 3, 4
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30 min Blood glucose
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood glucose at 30 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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60 min Blood glucose
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood glucose at 60 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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90 min Blood glucose
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood glucose at 90 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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120 min Blood glucose
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood glucose at 120 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Fasting Blood insulin
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Fasting blood insulin
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Clinical Investigation Day 1, 2, 3, 4
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30 min Blood insulin
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood insulin at 30 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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60 min Blood insulin
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood insulin at 60 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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90 min Blood insulin
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood insulin at 90 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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120 min Blood insulin
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood insulin at 120 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Fasting Hunger (VAS registered)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Fasting subjective appetite questionnaire.
Visual Analogue Scale
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Clinical Investigation Day 1, 2, 3, 4
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5 min Hunger (VAS registered)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Subjective appetite questionnaire.
Visual Analogue Scale at 5 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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15 min Hunger (VAS registered)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Subjective appetite questionnaire.
Visual Analogue Scale at 15 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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30 min Hunger (VAS registered)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Subjective appetite questionnaire.
Visual Analogue Scale at 30 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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45 min Hunger (VAS registered)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Subjective appetite questionnaire.
Visual Analogue Scale at 45 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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60 min Hunger (VAS registered)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Subjective appetite questionnaire.
Visual Analogue Scale at 60 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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120 min Hunger (VAS registered)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Subjective appetite questionnaire.
Visual Analogue Scale at 120 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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180 min Hunger (VAS registered)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Subjective appetite questionnaire.
Visual Analogue Scale at 180 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fasting Blood cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Fasting blood cholesterol
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Clinical Investigation Day 1, 2, 3, 4
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30 min Blood cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood cholesterol at 30 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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60 min Blood cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood cholesterol at 60 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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90 min Blood cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood cholesterol at 90 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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120 min Blood cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Blood cholesterol at 120 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Fasting Triglycerides
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Fasting triglycerides in serum
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Clinical Investigation Day 1, 2, 3, 4
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30 min Triglycerides
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Triglycerides in serum at 30 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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60 min Triglycerides
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Triglycerides in serum at 60 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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90 min Triglycerides
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Triglycerides in serum at 90 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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120 min Triglycerides
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Triglycerides in serum at 120 in post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Fasting HDL-cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Fasting HDL-cholesterol in serum
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Clinical Investigation Day 1, 2, 3, 4
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30 min HDL-cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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HDL-cholesterol in serum at 30 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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60 min HDL-cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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HDL-cholesterol in serum at 60 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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90 min HDL-cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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HDL-cholesterol in serum at 90 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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120 min HDL-cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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HDL-cholesterol in serum at 120 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Fasting LDL-cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Fasting LDL-cholesterol in serum
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Clinical Investigation Day 1, 2, 3, 4
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30 min LDL-cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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LDL-cholesterol in serum at 30 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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60 min LDL-cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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LDL-cholesterol in serum at 60 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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90 min LDL-cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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LDL-cholesterol in serum at 90 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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120 min LDL-cholesterol
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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LDL-cholesterol in serum at 120 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Fasting Alanine aminotransferase (ALT)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Fasting liver function marker ALT
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Clinical Investigation Day 1, 2, 3, 4
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120 min Alanine aminotransferase (ALT)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Liver function marker ALT at 120 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Fasting Aspartate aminotransferase (AST)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Fasting liver function marker AST
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Clinical Investigation Day 1, 2, 3, 4
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120 min Aspartate aminotransferase (AST)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Liver function marker AST at 120 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Weight
Time Frame: Visit 0 (screening), Clinical Investigation Day 4
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Anthropometry marker
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Visit 0 (screening), Clinical Investigation Day 4
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Height
Time Frame: Visit 0 (screening)
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Anthropometry marker
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Visit 0 (screening)
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Body Mass Index (BMI)
Time Frame: Visit 0 (screening), Clinical Investigation Day 4
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Anthropometry marker
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Visit 0 (screening), Clinical Investigation Day 4
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Waist Circumference (WC)
Time Frame: Visit 0 (screening)
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Anthropometry marker
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Visit 0 (screening)
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Hip Circumference (HC)
Time Frame: Visit 0 (screening)
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Anthropometry marker
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Visit 0 (screening)
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Waist-to-hip ratio (WHR)
Time Frame: Visit 0 (screening)
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Anthropometry marker
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Visit 0 (screening)
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Leeds Food Preference Questionnaire (LFPQ)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Change in food preference and food reward at 15-20 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Liking (VAS registered)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Liking and explicit wanting of the beverage at 5 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Fasting FG21
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Fasting FG21 concentration in serum
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Clinical Investigation Day 1, 2, 3, 4
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30 min FG21
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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FG21 concentration in serum at 30 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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60 min FG21
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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FG21 concentration in serum at 60 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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90 min FG21
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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FG21 concentration in serum at 90 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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120 min FG21
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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FG21 concentration in serum at 120 min post-intake
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Clinical Investigation Day 1, 2, 3, 4
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Consumers' Perspectives Questionnaire
Time Frame: Visit 0 (screening)
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Psychological health drivers (perceptions)
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Visit 0 (screening)
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Blood DNA Analysis
Time Frame: Clinical Investigation Day 1
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DNA analysis for genetic polymorphism presence
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Clinical Investigation Day 1
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24 hour food recall
Time Frame: Next day after each clinical investigation day (1, 2, 3, 4)
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Interview to know what the volunteers ate during the 24h following the beverage intake
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Next day after each clinical investigation day (1, 2, 3, 4)
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24 hour Gastro Intestinal side effects
Time Frame: Next day after each clinical investigation day (1, 2, 3, 4)
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Interview to know if the volunteers experienced side effects during the 24h following the beverage intake
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Next day after each clinical investigation day (1, 2, 3, 4)
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End of day questionnaire (VAS registered)
Time Frame: Clinical Investigation Day 1, 2, 3, 4
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Food cravings during the 8 h following the beverage intake
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Clinical Investigation Day 1, 2, 3, 4
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Risk factors for chronic disease
Time Frame: Visit 0 (screening)
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Baseline weight, height, BMI, WC and WHR, physical activity
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Visit 0 (screening)
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Socio-demographic questionnaire
Time Frame: Visit 0 (screening)
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Ethnicity, household and employment
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Visit 0 (screening)
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Eating Attitudes Test-26 (EAT-26)
Time Frame: Visit 0 (screening)
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Eating behaviour traits
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Visit 0 (screening)
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Short sugar Food Frequency Questionnaire (short sFFQ)
Time Frame: Visit 0 (screening)
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Habitual intake of sweet foods
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Visit 0 (screening)
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End of study survey
Time Frame: Clinical Investigation Day 4
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Perception and evaluation of the clinical trial
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Clinical Investigation Day 4
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Taste test (VAS registered)
Time Frame: Visit 0 (screening)
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Liking of the study beverage
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Visit 0 (screening)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 774293-WP2-P1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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