NCT05058144已完成不适用
Randomised, Placebo-controlled and Acute Study to Investigate the Metabolism of a Novel Alpha-Glucan in Adults
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年8月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Glucose concentration post ingestion of a test product
研究概览
简要总结
These are the characteristics of the project:
Monocentric:
Double blind randomized and crossover: you will test all the 3 products in random order.
详细描述
This study will be randomized, double blind, placebo-controlled, single-center, and 3x3 crossover in design. Eligible participants will be randomized to receive the below products in single dose and in different random sequence, as determined by the randomization system
- 50 g novel alpha glucan
- 50 g (rapidly digestible control)
- 15 g (dietary fiber)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy status (based on anamnesis) Body mass index (BMI) between 18.5 and 29.9 kg/m2 Able to understand and sign informed consent form.
排除标准
- •Pregnant or lactating women
- •Type I and type 2 diabetes
- •Known food allergy or intolerance to test product
- •Major medical/surgical event in the last 3 months potentially interfering with study procedures and assessments
- •Abnormal bowel transit, history of a gastrointestinal disorder (e.g., inflammatory bowel disease, diverticular diseases, colon cancer), or history of chronic constipation with passage of fewer than 3 spontaneous bowel movements per week on average or chronic or recurrent diarrhea with spontaneous bowel movements more often than 3 times daily
- •Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time, colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test
- •Recent episode of an acute gastrointestinal illness
- •Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
- •Volunteer who cannot be expected to comply with the protocol
- •Family or hierarchical relationships with Clinical Innovation Lab team
结局指标
主要结局
Glucose concentration post ingestion of a test product
时间窗: 180 minutes
postprandial glycemic response
次要结局
- insulin response post ingestion of a test product(180 minutes)
- intestinal hydrogen production as measured by breath hydrogen(240 minutes)
研究者
研究点 (1)
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