Work Package 2 Phase 1 - Beverages Study

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.

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).