Effect of Different Concentrations of Xylitol and Erythritol on the Release of Gastrointestinal Peptides and on Gastric Emptying Rates in Healthy Normal Weight Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Acute effect on cholecystokinin ( CCK) release
研究概览
简要总结
Xylitol and erythritol have become increasingly popular as sugar substitutes in the food industry. Both substances are freely available. While glucose ingestion stimulates satiation hormone secretion in the gut and slows down gastric emptying, artificial sweeteners such as aspartame, sucralose and acesulfame-K have no such effect. However, acute intake of 50g xylitol or 75g erythritol in 300mL tap water leads to a marked increase in the satiation hormones and induces a significant retardation in gastric emptying. The concentrations used to Show this effect were rather high (50g xylitol and 75g erythritol) and led to bloating and diarrhea in 60-70% of all subjects two hours after administration. The aim of the present study is to find an effective concentration of xylitol and erythritol still stimulating satiation hormone release without any gastrointestinal adverse events.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy normal weight subjects with a body-mass index of 19.0-24.9
- •Normal eating habits (no diets; no dietary changes; no special dietary habits, such as vegetarian/vegan)
- •Age 18-40 years
- •Stable body weight for at least three months
- •Informed Consent as documented by signature
排除标准
- •Pre-existing consumption of xylitol or erythritol on a regular basis (usage of xylitol or erythritol as sugar replacement; xylitol or erythritol containing toothpaste is allowed)
- •Regular intake of medications (except for oral contraceptives)
- •Evidence of relevant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other diseases at screening
- •Clinically relevant abnormalities in haematological laboratory parameters
- •Food allergies, food intolerance
- •Pregnancy
- •Participation in another study with investigational drug within the 30 days preceding and during the present study.
研究组 & 干预措施
Xylitol 7g in 300mL tap water
12 volunteers receive 7g xylitol in 300mL tap water via a nasogastric tube
干预措施: Xylitol 7g (Dietary Supplement)
Xylitol 17g in 300mL tap water
12 volunteers receive 17g xylitol in 300mL tap water via a nasogastric tube
干预措施: Xylitol 17g (Dietary Supplement)
Xylitol 35g in 300mL tap water
12 volunteers receive 35g xylitol in 300mL tap water via a nasogastric tube
干预措施: Xylitol 35g (Dietary Supplement)
Erythritol 10g in 300mL tap water
12 volunteers receive 10g erythritol in 300mL tap water via a nasogastric tube
干预措施: Erythritol 10g (Dietary Supplement)
Erythritol 25g in 300mL tap water
12 volunteers receive 25g erythritol in 300mL tap water via a nasogastric tube
干预措施: Erythritol 25g (Dietary Supplement)
Erythritol 50g in 300mL tap water
12 volunteers receive 50g erythritol in 300mL tap water via a nasogastric tube
干预措施: Erythritol 50g (Dietary Supplement)
结局指标
主要结局
Acute effect on cholecystokinin ( CCK) release
时间窗: changes from baseline to three hours after treatment
effect on CCK release measured by a commercially available ELISA kit (enzyme-linked immunosorbent assay)
次要结局
- Acute effects on gastric emptying(changes from baseline to three hours after treatment)
- Acute effects on subjective feelings of hunger and satiety(changes from baseline to three hours after treatment)