The Effect of Quinine on Food Intake: Oral Sham Feeding Versus Intragastric Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Ad libitum food intake
研究概览
简要总结
Rationale: The appearance of tastants in the small intestine following food ingestion results in the onset of digestion and absorption but can also result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. In this study, we aim to investigate the effects of oral sham feeding and intragastric delivery of a bitter tastant (quinine) on ad libitum food intake, satiation, gastrointestinal symptoms, and heart rate variability.
Objective: To investigate the effect of oral sham feeding and intragastric delivery of a bitter tastant on food intake.
Secondary Objective(s):
- To compare the effect of oral sham feeding and intragastric delivery of a bitter tastant on satiation.
- To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on gastrointestinal symptoms/complaints.
- To assess the effect of oral sham feeding and intragastric delivery of a bitter tastant on heart rate variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Participants and investigators will be blinded for the contents of the gastric capsule. Both cannot be blinded for the oral sham feeding
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Based on medical history and previous examination, no gastrointestinal complaints and/or gastrointestinal disorders can be defined.
- •Age ≥18 and ≤65 years. This study will include healthy adult subjects (male and female).
- •BMI ≥18 and ≤25 kg/m2
- •Body weight stable over at least the last 6 months (≤ 5% weight change allowed)
排除标准
- •History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- •Use of medication that can influence study end-points (to be discussed by medical doctor and principal investigator), including vitamin supplementation, within 14 days prior to testing
- •Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- •Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy and hysterectomy allowed, and other surgery upon judgement of medical doctor and principle investigator)
- •Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
- •Unwillingness to eat lasagna Bolognese meal
- •Pregnancy, lactation
- •Excessive alcohol consumption (>20 alcoholic consumptions per week)
- •Non-tasters of bitter
研究组 & 干预措施
Oral quinine, gastric placebo
Oral sham feeding of quinine and a gastric capsule containing placebo (cellulose)
干预措施: Quinine sham feeding quinine (Dietary Supplement)
Oral quinine, gastric placebo
Oral sham feeding of quinine and a gastric capsule containing placebo (cellulose)
干预措施: Gastric placebo (Dietary Supplement)
Oral placebo, gastric quinine
Oral sham feeding of placebo (tap water) and a gastric capsule containing quinine
干预措施: Gastric quinine (Dietary Supplement)
Oral placebo, gastric quinine
Oral sham feeding of placebo (tap water) and a gastric capsule containing quinine
干预措施: Oral sham feeding placebo (Dietary Supplement)
Oral quinine, gastric quinine
Oral sham feeding of quinine and a gastric capsule containing quinine
干预措施: Quinine sham feeding quinine (Dietary Supplement)
Oral quinine, gastric quinine
Oral sham feeding of quinine and a gastric capsule containing quinine
干预措施: Gastric quinine (Dietary Supplement)
Oral placebo, gastric placebo
Oral sham feeding of placebo (tap water) and a gastric capsule containing placebo (cellulose)
干预措施: Oral sham feeding placebo (Dietary Supplement)
Oral placebo, gastric placebo
Oral sham feeding of placebo (tap water) and a gastric capsule containing placebo (cellulose)
干预措施: Gastric placebo (Dietary Supplement)
结局指标
主要结局
Ad libitum food intake
时间窗: on each test day at T= 50, 50 minutes after ingestion of the capsule and sham-feeding
Difference in ad libitum meal intake (as measured during ad libitum pasta meal)
次要结局
- Heart rate variability(At T= -150 mins, T= -15 mins, T= 5 mins, and T= 35 mins, where T= -150 is 150 minutes before ingestion of standardized breakfast meal, T= 0 mins is ingestion of capsule and sham-feeding.)
- Satiation/satiety(At T= -20 mins, T= -10 mins, T=0 mins, T= 10 mins, T= 20 mins, T= 30 mins, T= 40 mins, T=50 and T= end, where T= 0 is ingestion of capsule and sham-feeding and T= end is whenever the participant finishes the test meal given at T= 50 mins.)
- GI-symptoms(At T= -20 mins, T= -10 mins, T=0 mins, T= 10 mins, T= 20 mins, T= 30 mins, T= 40 mins, T=50 and T= end, where T= 0 is ingestion of capsule and sham-feeding and T= end is whenever the participant finishes the test meal given at T= 50 mins.)