NCT06063096已完成不适用
Gastrointestinal Tolerance of D-allulose in Children: an Acute, Randomised, Double-blind, Placebo-controlled, Cross-over Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Tate & Lyle
- 入组人数
- 30
- 主要终点
- Difference in the number of participants experiencing at least one stool that met a Type 6 or Type 7 description on the Bristol Stool Chart, within 24 hours after study product intake
研究概览
简要总结
D-allulose, a low-calorie sugar, provides an attractive alternative to sucrose and added sugars in products. This study aimed to verify the tolerance of d-allulose in children, in doses that are Generally Recognised As Safe (GRAS) and below maximum tolerable levels on g/kg basis.
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)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children of 6 to 8 years of age
- •Weight-for-age between the 5th and the 90th percentile as per the Centre for Disease Control and Prevention Growth Charts
- •Accustomed to having lunch between 12.00 pm and 2.30 pm
- •Routinely had up to 3 bowel movements per day or as few as 3 bowel movements per week
- •Were able to drink 120 ml within 30 minutes
- •With parents willing to continue their child's normal food and beverage intake and physical activity throughout the duration of the study
- •With parents willing and able to attend for all 7 visits
排除标准
- •Any major trauma or surgical event within the 3 months prior to screening
- •History or presence of clinically significant endocrine or GI disorder
- •Functional GI Disorders in accordance with Rome III Diagnostic Questionnaire for Paediatric Functional GI Disorders
- •More than 1 loose stool in the 48 hours preceding dosing, that met a Type 6 or Type 7 description on the Bristol Stool Chart
- •Use of any prescription medication, including antibiotics, laxatives and steroids
- •Regular GI complaints, such as stomach upsets, diarrhoea, constipation, flatulence, abdominal colic
- •Known intolerance or sensitivity to any of the study products, abdominal or anorectal surgery
- •Psychiatric disorders, anxiety, and depression
- •Lactose intolerance
- •Use of supplements that may have affected GI system including laxatives, fibre, and iron supplements
- •Exposure to any non-registered drug product within 30 days prior to screening visit.
结局指标
主要结局
Difference in the number of participants experiencing at least one stool that met a Type 6 or Type 7 description on the Bristol Stool Chart, within 24 hours after study product intake
时间窗: within 24 hours after study product intake
Difference in the number of subjects experiencing at least one stool that met a Type 6 or Type 7 description on the Bristol Stool Chart
次要结局
- Number of subjects who experienced at least one loose or watery stool that met a Type 6 or Type 7 description on the Bristol Stool Chart(in a 24-hour period post-consumption of intervention)
- Frequency of the GI symptom event and frequency of participants reporting GI symptoms events by the severity and causality (i.e., related, not related) for each treatment group recorded at Visits 3, 5 and 7, for pre- and post-dose administration(in the 24-hour period post-consumption)
研究者
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