Acute and Repeated Impact of Sweeteners and Sweetness Enhancers on Food Behaviour, Physiology & Health (SWEET Work Package 2 Phase 2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 7
- 主要终点
- Composite Appetite Sensations Incremental Area Under the Curve
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind study. Neither the participant nor the investigator will be aware of the coding of food products used in the study.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Composite Appetite Sensations Incremental Area Under the Curve
时间窗: Clinical Investigation Day 1, 2, 3, 4, 5, 6
Incremental area under the curve (iAUC) for composite appetite sensations in response to each product. During each of the Clinical Investigation Days iAUC composite appetite will be measured 180 minutes post intake. The following sensations of appetite will be used in the composite measure: * hunger * fullness * desire to eat * prospective consumption Minimum value 0 Maximum value 100 Higher scores mean worse outcome
次要结局
- Cephalic and intestinal satiety biomarkers: Glucagon-like peptide-1 (GLP-1)(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
- Leeds Food Preference Questionnaire (LFPQ) Explicit Liking(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
- Blood Insulin Incremental Area Under the Curve(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
- Leeds Food Preference Questionnaire (LFPQ) Implicit Wanting(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
- Control of Eating Questionnaire (CoEQ): Craving for Savoury(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
- Blood Glucose Incremental Area Under the Curve(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
- Cephalic and intestinal satiety biomarkers: Ghrelin(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
- Leeds Food Preference Questionnaire (LFPQ) Relative preference(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
- Control of Eating Questionnaire (CoEQ): Craving Control(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
- Control of Eating Questionnaire (CoEQ): Positive Mood(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
- Leeds Food Preference Questionnaire (LFPQ) Explicit wanting(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
- Control of Eating Questionnaire (CoEQ): Craving for Sweet(Clinical Investigation Day 1, 2, 3, 4, 5, 6)
研究者
Dr Graham Finlayson
Professor
University of Leeds