Gastrointestinal Tolerance of Erythritol-containing Beverages in Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 6
- 主要终点
- Diarrhoea and/or significant gastrointestinal (GI) symptoms
研究概览
简要总结
Purpose of this study: assess the maximum tolerated bolus dose of erythritol, delivered in a clear beverage, compared with placebo (saccharose) in 4-6 year old children.
详细描述
The study is a randomized placebo-controlled, double-blind cross-over trial designed to determine the gastrointestinal (GI) responses and maximum tolerated dose of erythritol in young children as a single oral dose in a beverage in-between meals.
The children were divided into 4 dose groups. In each group of children, only one dose level was tested such that each child was exposed to only a single dose level versus placebo. The erythritol dose started at 5 grams and was increased by 10 g between each group of children only if the preceding dose level was found to have no significant GI tolerance effects. The effects on faecal parameters and gastrointestinal complaints were recorded in order to determine the threshold dose. After finding a significant difference in tolerance between erythritol and placebo in the 25 g dose cohort, a protocol amendment was approved allowing the investigators to study a dose of 20 g.
Test materials were prepared by Cargill, Vilvoorde, Belgium and supplied in bottles containing 250 mL of a noncarbonated fruit-flavoured (two flavours: strawberry and orange) clear drink sweetened with erythritol at four different dose levels: 5, 15, 20 and 25 g (equivalent to 2, 6, 8 and 10% w/v erythritol, respectively). Placebo was supplied in an identical manner but prepared with common nutritive carbohydrates (saccharose and maltodextrin) and providing an equivalent sweetness to that of the corresponding erythritol beverages (i.e.: 1.4, 4.2, 5.6 and 7% w/v).
In total 185 healthy young children aged 4-6 years were recruited at three clinical investigation centres after informed consent of both parents; 184 completed the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 4 to 6 years at Study D1 (day of consumption of the first beverage)
- •Body Mass Index ³ 13 kg/m²
- •Accustomed to having breakfast
- •Having a regular defecation frequency inferior or equal to two per day
- •Able to drink 250 mL within 15 minutes
- •Toilet-trained / able to use a potty (both at day and night)
- •Informed consent of both person entitled to parental rights
- •Person entitled to parental rights affiliated to the French social security
排除标准
- •Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before D1 of the study
- •Participation in any non-invasive clinical trial up to 30 days before D1 of this study, including blood sampling and/ or, intravenous, inhalatory administration of substances
- •Having a history of medical or surgical events that may significantly affect the study outcome, such as gastric and digestive diseases
- •Any current metabolic or endocrine disease, including diabetes mellitus
- •Use of medication, including antibiotics, laxatives and steroids
- •Regular gastrointestinal complaints, such as stomach upsets, diarrhoea, constipation, flatulence, abdominal colic
研究组 & 干预措施
5 g group
5g erythritol dissolved in 250 ml (2% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
干预措施: Placebo drink (Other)
15 g group
15g erythritol dissolved in 250 ml (6% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
干预措施: Placebo drink (Other)
15 g group
15g erythritol dissolved in 250 ml (6% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
干预措施: Erythritol drink (Other)
25 g group
25g erythritol dissolved in 250 ml (10% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
干预措施: Erythritol drink (Other)
25 g group
25g erythritol dissolved in 250 ml (10% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
干预措施: Placebo drink (Other)
20 g group
20g erythritol dissolved in 250 ml (8% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
干预措施: Erythritol drink (Other)
20 g group
20g erythritol dissolved in 250 ml (8% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
干预措施: Placebo drink (Other)
5 g group
5g erythritol dissolved in 250 ml (2% w/v) consumed within 15 min between meals (tested vs. 250 ml isosweet saccharose placebo under same conditions)
干预措施: Erythritol drink (Other)
结局指标
主要结局
Diarrhoea and/or significant gastrointestinal (GI) symptoms
时间窗: 48 hours
Diarrhoea = a single watery stool (Bristol Stool Scale Score of 7) and/or \>3 faeces (regardless of consistency) in a 24 h period. Significant GI symptoms = any GI symptoms having a severity recorded as "severe intensity" in the symptom diary
次要结局
- Stool frequency(48 hours)
- Stool consistency(48 hours)
- Gastrointestinal symptoms(24 hours)
- Urinary erythritol excretion(24 hours)