Work Package 2 Phase 1 - Beverages Study

Overweight and Obesity Clinical Trial

— SWEET-WP2-P1  

Official title:

Sweeteners and Sweetness Enhancers: Short-term Impact on Food Behaviour, Physiology & Health (Phase 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483180
• Other study ID #: 774293-WP2-P1
• Status: Completed
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Glycemic Index
• Overweight
• Overweight and Obesity

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