Effects of Oral Pre-loads on Subsequent Energy Intake, Gastrointestinal Hormones, Glycemic Control, Appetite-related Sensations, and Gastrointestinal Tolerance
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
- 1
- 主要终点
- Effect of erythritol on energy intake during a subsequent ad libitum test meal
研究概览
简要总结
The aim of this project is to investigate the effect of erythritol (given as pre-load), compared to sucrose, sucralose, and water on energy intake during a subsequent ad libitum test meal in healthy participants.
Furthermore, the release of GI hormones, glycemic control, appetite-related sensations, GI tolerance, sweetness and liking in response to the pre-loads will be investigated.
详细描述
The subjects will participate in four study days. The screening will last 60 minutes, the study days about 4.5 hours each. After a simple-carbohydrate standard dinner, the subjects have to do an overnight fast until the next morning. Subjects will receive fixed equisweet doses of sucrose (33.5g), erythritol (50g), sucralose (0.0558g), or water as oral pre-loads in a blinded, randomized (counterbalanced) fashion (t = -15 min). Fifteen minutes after the administration (t = 0 min), a standard solid test meal will be presented and ad libitum calorie intake will be measured. The end of the test meal will be after 20 minutes or as soon as the subject stops eating for more than 5 minutes. Blood samples (to measure: glycemic control and GI hormones) will be collected at t = -16, t = -1, t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 min and appetite-related sensation rating will be collected at t = -16, t = -1, t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 min. GI symptoms and nausea are assessed at t = -16, -1, 30, 60, 120 and 180 min. At t = -10 min subjects are asked to rate the perceived sweetness and liking of the pre-load and at t = 180 min the perceived liking of the test meal.
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 subjects with a body-mass index of 19.0-24.9
- •Normal eating habits (eating breakfast; no diets; no dietary changes; no vegetarians/vegans, no intolerances/allergies)
- •Age 18-55 years
- •Stable body weight (+/- 5%) for at least three months
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
排除标准
- •Shift worker
- •Fructose intolerance
- •Pre-existing consumption of erythritol and/or sucralose more than once a week
- •Substance abuse
- •Regular intake of medications, except anticontraceptive
- •Chronic or clinically relevant acute infections
- •Pregnancy: although no contraindication, pregnancy might influence metabolic state. Women who are pregnant or have the intention to become pregnant during the course of the study are excluded. Female participants of childbearing age have to use safe contraception (oral, injectable, or implantable contraceptives, intrauterine contraceptive devices, or tubectomy). In female participants a urine pregnancy test is carried out upon screening.
- •Participation in another study with investigational drug within the 30 days preceding and during the present study.
研究组 & 干预措施
Water
20 volunteers receive 300mL tap water as an oral pre-load.
干预措施: Water (Dietary Supplement)
Sucralose
20 volunteers receive 0.0558g sucralose dissolved in 300mL tap water as an oral pre-load.
干预措施: Sucralose (Dietary Supplement)
Sucrose
20 volunteers receive 33.5g sucrose dissolved in 300mL tap water as an oral pre-load.
干预措施: Sucrose (Dietary Supplement)
Erythritol
20 volunteers receive 50g erythritol dissolved in 300mL tap water as an oral pre-load.
干预措施: Erythritol (Dietary Supplement)
结局指标
主要结局
Effect of erythritol on energy intake during a subsequent ad libitum test meal
时间窗: Total energy intake will be measured from t = 0 until t = 20 minutes or as soon as the as the subject stops eating for more than 5 minutes.
Fifteen minutes after the administration of the pre-loads (t = 0 minutes), a standard solid test meal will be presented and ad libitum calorie intake will be measured.
次要结局
- Effects on GI hormone response - CCK(Blood will be drawn at the following time points: t = -16, t = -1 (before the administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).)
- Effects on glycemic control - plasma insulin(Blood will be drawn at the following time points: t = -16, t = -1 (before the administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).)
- Effects on glycemic control - plasma glucose(Blood will be drawn at the following time points: t = -16, t = -1 (before administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).)
- Effects on appetite-related sensations(Visual analogue scales will be recorded at the following time points: t = -16, t = -1 (before the administration of the pre-loads), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-loads).)
- Sweetness of pre-load(Sweetness of the pre-load will be recorded at t = -10 minutes.)
- Liking ot the pre-load(Liking of the pre-load will be recorded at t = -10 minutes.)
- Effects on GI hormone response - GLP-1(Blood will be drawn at the following time points: t = -16, t = -1 (before the administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).)
- Effects on GI hormone response - PYY(Blood will be drawn at the following time points :t = -16, t = -1 (before the administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).)
- Effects on GI hormone response - ghrelin(Blood will be drawn at the following time points: t = -16, t = -1 (before the administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).)
- Liking of the test meal(Liking of the test meal will be recorded at t = 180 minutes.)
- Effects on glycemic control - plasma c-peptide(Blood will be drawn at the following time points: t = -16, t = -1 (before administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).)
- Effects on glycemic control - plasma glucagon(Blood will be drawn at the following time points: t = -16, t = -1 (before the administration of the pre-load), t = 15, t = 30, t = 60, t = 90, t = 120, t = 150, t = 180 minutes (after the administration of the pre-load).)
- Effects on GI tolerance(GI tolerance will be recorded at t = -16, -1 (before the administration of the pre-load), 30, 60, 120 and 180 minutes (after the administration of the pre-load).)