Assessment of Reward Responses to Erythritol Using Flavor Preference Learning and Its Effects on Gastrointestinal Hormones, Glycemic Control, Appetite-related Sensations and Emotional State
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Assessment of the change of explicit wanting (reward response) to oral erythritol versus sucrose and sucralose as change from baseline to post-test visit.
研究概览
简要总结
The aim of this project is to investigate the reward responses to oral erythritol compared to sucrose and sucralose using flavor preference learning in healthy participants. In addition, the release of GI hormones, glycemic control, appetite-related sensations, and emotional state in response to erythritol will be investigated.
详细描述
This trial is a randomized, double-blind, cross-over study; the project set-up will be single-centre, national. The study is composed of six visits: one screening visit, one pre-test visit, three conditioning visits, and one post-test visit. The screening and pre-test will last about two hours, the conditioning days and the post-test day about 4 hours each. During the screening participants take part in a 6-n-propylthiouracil (PROP) sensitivity test to exclude potential supertasters. Moreover, the participants will rate explicit liking and explicit wanting of 10 non-caloric flavored and colored beverages in a randomized order (flavor preference learning). The pre-test visit consists of two parts. First, a chemosensory sweetness matching will be performed, during which we will establish dose-response relationships for perceived sweetness of sucrose, erythritol, and sucralose using equisweet watery solutions across a range of concentrations. Second, the participants will perform a triangle test to ensure that they cannot distinguish the matched erythritol and sucralose solutions from a 10% sucrose solution.
During the 3 conditioning visits, participants will be presented with three conditioning trials (at t = 0, 45, and 90min), each consisting of drinking 100mL of the flavored drink (CS) paired with one of the sweet substances (US = erythritol, sucrose, or sucralose).
In post-test visit, preference for each of the 3 flavored CS drinks will be assessed and a computerized forced choice task will be completed by the participants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy normal weight participants with a body-mass index (BMI) of 19.0-24.9 kg/m2
- •Age 18-55 years
- •Stable body weight (±5%) for at least three months
- •Able to give informed consent as documented by signature
- •3 drinks rated as neutral and novel (from the flavor preference learning)
排除标准
- •Non-taster (deficits of taste and smell) or supertaster
- •Fructose intolerance
- •Shift worker
- •Pre-existing regular consumption of erythritol and/or sucralose and/or aspartame (>1/week)
- •Substance abuse (more than 1 glass wine/beer per day; consumption of cannabis, cocaine, heroin, etc.)
- •Regular intake of medications, except contraceptives
- •Chronic or clinically relevant acute infections
- •Pregnancy: although no contraindication, pregnancy might influence metabolic state.
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
- •Pre-existing diet (vegetarian, vegan, sugar free)
- •Inability to follow procedures due to psychological disorders or insufficient knowledge of project language (German)
- •Calculated dose of erythritol outside the range of 30-60g (per 300mL) (from the sweetness matching)
结局指标
主要结局
Assessment of the change of explicit wanting (reward response) to oral erythritol versus sucrose and sucralose as change from baseline to post-test visit.
时间窗: from baseline to post-test visit (at t = 0min, t = 45min and t = 90min)
Beverages are consumed during the screening visit, conditioning visits and the post-test visit. The beverages will be consumed at t = 0min, t = 45min and t = 90min and afterwards explicit wanting will be assessed. Explicit wanting of the consumed beverages is assessed by Visual Analogue Scale (VAS) as "How much do you want to drink of the drink". The Visual Analogue Scale consists of a horizontal, unstructured, 10 cm line representing the minimum (0.0 points) labeled with "not much at all" to the maximum rating (10.0 points) labeled with "very much". Participants are instructed to draw a dash in the answer line to indicate the magnitude of their subjective sensation at the present time point.
次要结局
- Effects on glycemic control - plasma c-peptide(Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.)
- Effects on glycemic control - plasma glucose(Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.)
- Emotional state(The emotional state will be assessed at t = -1, 0, 45, 90 min.)
- Effects on reward response - explicit liking(The beverages will be consumed at t = 0min, t = 45min and t = 90min and afterwards explicit liking will be rated.)
- Effects on reward response - desire to drink(The beverages will be consumed at t = 0min, t = 45min and t = 90min and afterwards desire to drink will be rated.)
- Effects on glycemic control - plasma insulin(Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.)
- Effects on glycemic control - plasma glucagon(Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.)
- Effects on GI hormone response - GLP-1(Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.)
- Effects on GI hormone response - ghrelin(Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.)
- Effects on appetite-related sensations (hunger, thirst, satiety)(Appetite-related sensations will be assessed at t = -1, 0, 15, 30, 44, 45, 60, 75, 89, 90, 105, 120, 134min.)
- Effects on reward response - implicit wanting(The computerized forced choice task will be performed at t = 135 min during the post-test visit.)
- Effects on GI hormone response - PYY(Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.)
- Effects on GI hormone response - CCK(Blood will be drawn at baseline (at t = -1min) and at t = 15, 30, 44, 60, 75, 89, 105, 120, and 134min.)