Glycemic Index, Overweight and Obesity
Conditions
Brief 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.
Interventions
OTHERComparison 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
Sponsors
University of Leeds
University of Copenhagen
University of Liverpool
University of Surrey
Bioiatriki HEALTHCARE GROUP
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blind study. Neither the participant nor the investigator will be aware of the coding of beverages used in the study.
Intervention model description
Multi-centre crossover study with 4 conditions using balanced block randomisation. The three centres will follow different randomisation sequences but will all test the same 4 conditions (University of Navarra, University of Copenhagen, University of Liverpool).
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5 min Hunger (VAS registered) | Clinical Investigation Day 1, 2, 3, 4 | Subjective appetite questionnaire. Visual Analogue Scale at 5 min post-intake |
| Fasting Hunger (VAS registered) | Clinical Investigation Day 1, 2, 3, 4 | Fasting subjective appetite questionnaire. Visual Analogue Scale |
| 120 min Blood insulin | Clinical Investigation Day 1, 2, 3, 4 | Blood insulin at 120 min post-intake |
| 90 min Blood insulin | Clinical Investigation Day 1, 2, 3, 4 | Blood insulin at 90 min post-intake |
| 180 min Hunger (VAS registered) | Clinical Investigation Day 1, 2, 3, 4 | Subjective appetite questionnaire. Visual Analogue Scale at 180 min post-intake |
| 60 min Blood insulin | Clinical Investigation Day 1, 2, 3, 4 | Blood insulin at 60 min post-intake |
| 120 min Hunger (VAS registered) | Clinical Investigation Day 1, 2, 3, 4 | Subjective appetite questionnaire. Visual Analogue Scale at 120 min post-intake |
| 60 min Hunger (VAS registered) | Clinical Investigation Day 1, 2, 3, 4 | Subjective appetite questionnaire. Visual Analogue Scale at 60 min post-intake |
| 45 min Hunger (VAS registered) | Clinical Investigation Day 1, 2, 3, 4 | Subjective appetite questionnaire. Visual Analogue Scale at 45 min post-intake |
| 30 min Hunger (VAS registered) | Clinical Investigation Day 1, 2, 3, 4 | Subjective appetite questionnaire. Visual Analogue Scale at 30 min post-intake |
| 15 min Hunger (VAS registered) | Clinical Investigation Day 1, 2, 3, 4 | Subjective appetite questionnaire. Visual Analogue Scale at 15 min post-intake |
| 120 min Blood glucose | Clinical Investigation Day 1, 2, 3, 4 | Blood glucose at 120 min post-intake |
| Fasting Blood insulin | Clinical Investigation Day 1, 2, 3, 4 | Fasting blood insulin |
| 30 min Blood insulin | Clinical Investigation Day 1, 2, 3, 4 | Blood insulin at 30 min post-intake |
| Fasting Blood glucose | Clinical Investigation Day 1, 2, 3, 4 | Fasting blood glucose |
| 30 min Blood glucose | Clinical Investigation Day 1, 2, 3, 4 | Blood glucose at 30 min post-intake |
| 60 min Blood glucose | Clinical Investigation Day 1, 2, 3, 4 | Blood glucose at 60 min post-intake |
| 90 min Blood glucose | Clinical Investigation Day 1, 2, 3, 4 | Blood glucose at 90 min post-intake |
| Blood glucose area under the curve (AUC) | Clinical Investigation Day 1, 2, 3, 4 | Area Under the Curve (AUC) for blood glucose (120 min post-intake) |
| Blood Insulin AUC | Clinical Investigation Day 1, 2, 3, 4 | Area Under the Curve for blood Insulin (120 min post-intake) |
| Hunger iAUC | Clinical Investigation Day 1, 2, 3, 4 | Incremental Area Under the Curve for hunger (120 min post-intake) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Alanine aminotransferase (ALT) | Clinical Investigation Day 1, 2, 3, 4 | Fasting liver function marker ALT |
| 120 min Alanine aminotransferase (ALT) | Clinical Investigation Day 1, 2, 3, 4 | Liver function marker ALT at 120 min post-intake |
| Fasting Aspartate aminotransferase (AST) | Clinical Investigation Day 1, 2, 3, 4 | Fasting liver function marker AST |
| 120 min Aspartate aminotransferase (AST) | Clinical Investigation Day 1, 2, 3, 4 | Liver function marker AST at 120 min post-intake |
| Weight | Visit 0 (screening), Clinical Investigation Day 4 | Anthropometry marker |
| Height | Visit 0 (screening) | Anthropometry marker |
| Body Mass Index (BMI) | Visit 0 (screening), Clinical Investigation Day 4 | Anthropometry marker |
| Waist Circumference (WC) | Visit 0 (screening) | Anthropometry marker |
| Hip Circumference (HC) | Visit 0 (screening) | Anthropometry marker |
| Waist-to-hip ratio (WHR) | Visit 0 (screening) | Anthropometry marker |
| Leeds Food Preference Questionnaire (LFPQ) | Clinical Investigation Day 1, 2, 3, 4 | Change in food preference and food reward at 15-20 min post-intake |
| Fasting FG21 | Clinical Investigation Day 1, 2, 3, 4 | Fasting FG21 concentration in serum |
| 30 min FG21 | Clinical Investigation Day 1, 2, 3, 4 | FG21 concentration in serum at 30 min post-intake |
| 60 min FG21 | Clinical Investigation Day 1, 2, 3, 4 | FG21 concentration in serum at 60 min post-intake |
| 90 min FG21 | Clinical Investigation Day 1, 2, 3, 4 | FG21 concentration in serum at 90 min post-intake |
| 120 min FG21 | Clinical Investigation Day 1, 2, 3, 4 | FG21 concentration in serum at 120 min post-intake |
| Liking (VAS registered) | Clinical Investigation Day 1, 2, 3, 4 | Liking and explicit wanting of the beverage at 5 min post-intake |
| Fasting Blood cholesterol | Clinical Investigation Day 1, 2, 3, 4 | Fasting blood cholesterol |
| 30 min Blood cholesterol | Clinical Investigation Day 1, 2, 3, 4 | Blood cholesterol at 30 min post-intake |
| 60 min Blood cholesterol | Clinical Investigation Day 1, 2, 3, 4 | Blood cholesterol at 60 min post-intake |
| 90 min Blood cholesterol | Clinical Investigation Day 1, 2, 3, 4 | Blood cholesterol at 90 min post-intake |
| 120 min Blood cholesterol | Clinical Investigation Day 1, 2, 3, 4 | Blood cholesterol at 120 min post-intake |
| Fasting Triglycerides | Clinical Investigation Day 1, 2, 3, 4 | Fasting triglycerides in serum |
| 30 min Triglycerides | Clinical Investigation Day 1, 2, 3, 4 | Triglycerides in serum at 30 min post-intake |
| 60 min Triglycerides | Clinical Investigation Day 1, 2, 3, 4 | Triglycerides in serum at 60 min post-intake |
| 90 min Triglycerides | Clinical Investigation Day 1, 2, 3, 4 | Triglycerides in serum at 90 min post-intake |
| 120 min Triglycerides | Clinical Investigation Day 1, 2, 3, 4 | Triglycerides in serum at 120 in post-intake |
| Fasting HDL-cholesterol | Clinical Investigation Day 1, 2, 3, 4 | Fasting HDL-cholesterol in serum |
| 30 min HDL-cholesterol | Clinical Investigation Day 1, 2, 3, 4 | HDL-cholesterol in serum at 30 min post-intake |
| 60 min HDL-cholesterol | Clinical Investigation Day 1, 2, 3, 4 | HDL-cholesterol in serum at 60 min post-intake |
| 90 min HDL-cholesterol | Clinical Investigation Day 1, 2, 3, 4 | HDL-cholesterol in serum at 90 min post-intake |
| 120 min HDL-cholesterol | Clinical Investigation Day 1, 2, 3, 4 | HDL-cholesterol in serum at 120 min post-intake |
| Fasting LDL-cholesterol | Clinical Investigation Day 1, 2, 3, 4 | Fasting LDL-cholesterol in serum |
| 30 min LDL-cholesterol | Clinical Investigation Day 1, 2, 3, 4 | LDL-cholesterol in serum at 30 min post-intake |
| 60 min LDL-cholesterol | Clinical Investigation Day 1, 2, 3, 4 | LDL-cholesterol in serum at 60 min post-intake |
| 90 min LDL-cholesterol | Clinical Investigation Day 1, 2, 3, 4 | LDL-cholesterol in serum at 90 min post-intake |
| 120 min LDL-cholesterol | Clinical Investigation Day 1, 2, 3, 4 | LDL-cholesterol in serum at 120 min post-intake |
Other
| Measure | Time frame | Description |
|---|---|---|
| Consumers' Perspectives Questionnaire | Visit 0 (screening) | Psychological health drivers (perceptions) |
| Taste test (VAS registered) | Visit 0 (screening) | Liking of the study beverage |
| End of study survey | Clinical Investigation Day 4 | Perception and evaluation of the clinical trial |
| Short sugar Food Frequency Questionnaire (short sFFQ) | Visit 0 (screening) | Habitual intake of sweet foods |
| Eating Attitudes Test-26 (EAT-26) | Visit 0 (screening) | Eating behaviour traits |
| Socio-demographic questionnaire | Visit 0 (screening) | Ethnicity, household and employment |
| Risk factors for chronic disease | Visit 0 (screening) | Baseline weight, height, BMI, WC and WHR, physical activity |
| End of day questionnaire (VAS registered) | Clinical Investigation Day 1, 2, 3, 4 | Food cravings during the 8 h following the beverage intake |
| 24 hour Gastro Intestinal side effects | Next day after each clinical investigation day (1, 2, 3, 4) | Interview to know if the volunteers experienced side effects during the 24h following the beverage intake |
| 24 hour food recall | Next day after each clinical investigation day (1, 2, 3, 4) | Interview to know what the volunteers ate during the 24h following the beverage intake |
| Blood DNA Analysis | Clinical Investigation Day 1 | DNA analysis for genetic polymorphism presence |
Countries
Denmark, Spain, United Kingdom
Outcome results
None listed