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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04483180
Other study ID # 774293-WP2-P1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 14, 2020
Est. completion date June 30, 2021

Study information

Verified date June 2020
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark University of Copenhagen Frederiksberg
Spain Centre for Nutrition Research, University of Navarra Pamplona Navarra
United Kingdom University of Liverpool Liverpool

Sponsors (6)

Lead Sponsor Collaborator
Clinica Universidad de Navarra, Universidad de Navarra Bioiatriki HEALTHCARE GROUP, University of Copenhagen, University of Leeds, University of Liverpool, University of Surrey

Countries where clinical trial is conducted

Denmark,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Consumers' Perspectives Questionnaire Psychological health drivers (perceptions) Visit 0 (screening)
Other Blood DNA Analysis DNA analysis for genetic polymorphism presence Clinical Investigation Day 1
Other 24 hour food recall Interview to know what the volunteers ate during the 24h following the beverage intake Next day after each clinical investigation day (1, 2, 3, 4)
Other 24 hour Gastro Intestinal side effects Interview to know if the volunteers experienced side effects during the 24h following the beverage intake Next day after each clinical investigation day (1, 2, 3, 4)
Other End of day questionnaire (VAS registered) Food cravings during the 8 h following the beverage intake Clinical Investigation Day 1, 2, 3, 4
Other Risk factors for chronic disease Baseline weight, height, BMI, WC and WHR, physical activity Visit 0 (screening)
Other Socio-demographic questionnaire Ethnicity, household and employment Visit 0 (screening)
Other Eating Attitudes Test-26 (EAT-26) Eating behaviour traits Visit 0 (screening)
Other Short sugar Food Frequency Questionnaire (short sFFQ) Habitual intake of sweet foods Visit 0 (screening)
Other End of study survey Perception and evaluation of the clinical trial Clinical Investigation Day 4
Other Taste test (VAS registered) Liking of the study beverage Visit 0 (screening)
Primary Blood glucose area under the curve (AUC) Area Under the Curve (AUC) for blood glucose (120 min post-intake) Clinical Investigation Day 1, 2, 3, 4
Primary Blood Insulin AUC Area Under the Curve for blood Insulin (120 min post-intake) Clinical Investigation Day 1, 2, 3, 4
Primary Hunger iAUC Incremental Area Under the Curve for hunger (120 min post-intake) Clinical Investigation Day 1, 2, 3, 4
Primary Fasting Blood glucose Fasting blood glucose Clinical Investigation Day 1, 2, 3, 4
Primary 30 min Blood glucose Blood glucose at 30 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 60 min Blood glucose Blood glucose at 60 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 90 min Blood glucose Blood glucose at 90 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 120 min Blood glucose Blood glucose at 120 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary Fasting Blood insulin Fasting blood insulin Clinical Investigation Day 1, 2, 3, 4
Primary 30 min Blood insulin Blood insulin at 30 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 60 min Blood insulin Blood insulin at 60 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 90 min Blood insulin Blood insulin at 90 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 120 min Blood insulin Blood insulin at 120 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary Fasting Hunger (VAS registered) Fasting subjective appetite questionnaire. Visual Analogue Scale Clinical Investigation Day 1, 2, 3, 4
Primary 5 min Hunger (VAS registered) Subjective appetite questionnaire. Visual Analogue Scale at 5 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 15 min Hunger (VAS registered) Subjective appetite questionnaire. Visual Analogue Scale at 15 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 30 min Hunger (VAS registered) Subjective appetite questionnaire. Visual Analogue Scale at 30 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 45 min Hunger (VAS registered) Subjective appetite questionnaire. Visual Analogue Scale at 45 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 60 min Hunger (VAS registered) Subjective appetite questionnaire. Visual Analogue Scale at 60 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 120 min Hunger (VAS registered) Subjective appetite questionnaire. Visual Analogue Scale at 120 min post-intake Clinical Investigation Day 1, 2, 3, 4
Primary 180 min Hunger (VAS registered) Subjective appetite questionnaire. Visual Analogue Scale at 180 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary Fasting Blood cholesterol Fasting blood cholesterol Clinical Investigation Day 1, 2, 3, 4
Secondary 30 min Blood cholesterol Blood cholesterol at 30 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 60 min Blood cholesterol Blood cholesterol at 60 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 90 min Blood cholesterol Blood cholesterol at 90 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 120 min Blood cholesterol Blood cholesterol at 120 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary Fasting Triglycerides Fasting triglycerides in serum Clinical Investigation Day 1, 2, 3, 4
Secondary 30 min Triglycerides Triglycerides in serum at 30 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 60 min Triglycerides Triglycerides in serum at 60 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 90 min Triglycerides Triglycerides in serum at 90 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 120 min Triglycerides Triglycerides in serum at 120 in post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary Fasting HDL-cholesterol Fasting HDL-cholesterol in serum Clinical Investigation Day 1, 2, 3, 4
Secondary 30 min HDL-cholesterol HDL-cholesterol in serum at 30 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 60 min HDL-cholesterol HDL-cholesterol in serum at 60 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 90 min HDL-cholesterol HDL-cholesterol in serum at 90 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 120 min HDL-cholesterol HDL-cholesterol in serum at 120 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary Fasting LDL-cholesterol Fasting LDL-cholesterol in serum Clinical Investigation Day 1, 2, 3, 4
Secondary 30 min LDL-cholesterol LDL-cholesterol in serum at 30 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 60 min LDL-cholesterol LDL-cholesterol in serum at 60 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 90 min LDL-cholesterol LDL-cholesterol in serum at 90 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 120 min LDL-cholesterol LDL-cholesterol in serum at 120 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary Fasting Alanine aminotransferase (ALT) Fasting liver function marker ALT Clinical Investigation Day 1, 2, 3, 4
Secondary 120 min Alanine aminotransferase (ALT) Liver function marker ALT at 120 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary Fasting Aspartate aminotransferase (AST) Fasting liver function marker AST Clinical Investigation Day 1, 2, 3, 4
Secondary 120 min Aspartate aminotransferase (AST) Liver function marker AST at 120 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary Weight Anthropometry marker Visit 0 (screening), Clinical Investigation Day 4
Secondary Height Anthropometry marker Visit 0 (screening)
Secondary Body Mass Index (BMI) Anthropometry marker Visit 0 (screening), Clinical Investigation Day 4
Secondary Waist Circumference (WC) Anthropometry marker Visit 0 (screening)
Secondary Hip Circumference (HC) Anthropometry marker Visit 0 (screening)
Secondary Waist-to-hip ratio (WHR) Anthropometry marker Visit 0 (screening)
Secondary Leeds Food Preference Questionnaire (LFPQ) Change in food preference and food reward at 15-20 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary Liking (VAS registered) Liking and explicit wanting of the beverage at 5 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary Fasting FG21 Fasting FG21 concentration in serum Clinical Investigation Day 1, 2, 3, 4
Secondary 30 min FG21 FG21 concentration in serum at 30 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 60 min FG21 FG21 concentration in serum at 60 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 90 min FG21 FG21 concentration in serum at 90 min post-intake Clinical Investigation Day 1, 2, 3, 4
Secondary 120 min FG21 FG21 concentration in serum at 120 min post-intake Clinical Investigation Day 1, 2, 3, 4
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