impact of sweeteners on behaviour, physiology & health

Conditions: Eating Behavior

Summary: this study aims to evaluate the acute (1-day) and repeated (2-week) effects of combinations of sweeteners \& sweetness enhancer blends on metabolic, sensory, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preferences and health.

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, neuro-behavioural and microbiota-mediated processes involved in satiety, consumer preference and health, and to explore mechanistic processes, genetic background, safety issues and consumer perspectives. there are 5 products being tested in 3 different formulations (sucrose-sweetened control vs 2 reformulated with s\&se). each product will be tested at 2 intervention sites in double-blind cross-over trials with 48 subjects (24 per site) tested per product. therefore a total of 240 subjects will take part across the 5 intervention sites (navarra, leeds, liverpool, copenhagen, lyon). using identical procedures each trial will consist of 2 clinical investigation days (cids) scheduled 12 days apart for each of the 3 product formulations. a 2-week wash-out period will be given between formulations. the total duration of wp2 phase 2 is 12 months, including a 5-month duration for each cross-over trial.

Eligibility criteria:
inclusion criteria: * bmi: 25 to 35 kg/m2 * use of contraceptive methods or not planning to become pregnant for the duration of the study (women only) * regular consumption of sugar-containing foods and willing to consume sugar and artificially-sweetened food products. * liking of the intervention foods defined by a response of yes for the product during the pre-screening interview and a score of 40% or above on the liking visual analogue scale for the sucrose-sweetened control product. * able to participate on the clinical investigation days 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). * able to understand and be willing to sign the informed consent form, and to follow all the study procedures and requirements. * capacity to store at-home intervention quantity of intervention product exclusion criteria: * blood donation \< 3 month prior to study or for full duration of the study. * 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 ≥20 on the eating attitudes test. * currently dieting to lose weight. * having lost or gained \>4.5 kg in the last 3 months. * smoking or having quit \<3 months prior to study. * habitually consuming \>14 units/week of alcohol in women or \>21 units/week in men in the last 3 months. * performing \>10 h of intense physical activity per week in the last 3 months. * 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. * pregnancy, lactation (women only) * 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 responsible clinician. * simultaneous participation in other relevant clinical intervention studies. * previous university or college training related to eating behaviour research. * self-reported eating disorders. * diagnosed anaemia. * diagnosed diabetes mellitus. * abnormal 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 cardiovascular 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). * 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).

Keywords: appetite food preferences sweeteners sweetness enhancers