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
干预措施
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
研究组 & 干预措施
novel alpha glucan
Experimental
50g novel alpha glucan dissolved in 300ml water
干预措施: Drinkable solution (Dietary Supplement)
glucose syrup
Active Comparator
50g dissolved in 300ml water
干预措施: Drinkable solution (Dietary Supplement)
Inulin
Active Comparator
15g Inulin dissolved in 300ml water
干预措施: Drinkable solution (Dietary Supplement)
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)
Loading locations...
相似试验
已完成
不适用
Clinical Trial to Evaluate Effectiveness of a Probiotic Preparation Administered to Patients With Alopecia AreataAlopecia AreataNCT05599607Bioithas SL26
终止
不适用
Clinical Study to Evaluate the Performance of Synthetic Polyurethane Male CondomsPerformance of Synthetic Polyurethane Male CondomNCT05536336Okamoto Industries, Inc.188
进行中（未招募）
1 期
Study on the efficacy of laser treatment using a dye as an enhancervenous and capillary vascular malformationsMedDRA version: 14.1Level: HLTClassification code 10047091Term: Vascular malformations and acquired anomaliesSystem Organ Class: 10047065 - Vascular disordersEUCTR2009-009956-20-DEFree State of Bavaria rep. by the Univ. of Regensburg, rep. by the Regensburg Univ. Hospital
已完成
2 期
Jinhua Qinggan Granules in the Treatment of COVID-19COVID-19NCT04723524University of Karachi402
已完成
不适用
Safety and Efficacy of ActiGraft Pro Compared to Standard of Care in DFUsDiabetic FootChronic UlcerNCT04185558RedDress Ltd.119