Randomised, Placebo-controlled Chronic Study to Investigate Gastrointestinal Tolerability of a Novel Alpha Glucan in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Gastrointestinal Symptom Rating Scale (GSRS)
研究概览
简要总结
This study aims to evaluate the gastrointestinal tolerance of chronic consumption (7 days) of a novel alpha glucan compared to a rapidly available carbohydrate (glucose syrup).
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:
- novel alpha glucan (80 g/day)
- novel alpha glucan (180 g/day)
- glucose syrup (180 g/day)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participant,
- •Healthy status (based on anamnesis),
- •Age between 18 and 65 years,
- •Body mass index (BMI) between 18.5 and 29.9 kg/m2,
- •Able to understand and sign informed consent form,
- •Having a smartphone with Android or iOS version compatible with Patient Cloud application
排除标准
- •Fasting plasma glucose higher or equal to 6,1 mmol /L at screening,
- •Type I and type 2 diabetes,
- •Pregnant or lactating women,
- •Known food allergy or intolerance to test products,
- •Treatment with anorectic drugs, glucose-lowering drugs, steroids, medications known to affect glucose metabolism and/or gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption,
- •Colonoscopy, irrigoscopy or other bowel cleansing procedures four weeks prior the test,
- •Any concomitant medication potentially interfering with study procedures and assessment: such as antibiotics, antiacids, or other medications impacting transit time,
- •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,
- •Recent episode of an acute gastrointestinal illness,
- •Habitual consumption of more than four servings per day of high-fiber foods or extreme dietary habits (e.g. very low carbohydrate diet),
- •Ongoing or recent weight loss interventions (e.g. dietary weight loss programs),
- •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,
- •Score of "severe" symptom for any of the symptoms included in the gastrointestinal symptom questionnaire,
- •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
Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: Throughout 7 days of treatment
Validated questionnaire exploring the presence and severity of GI symptoms over the previous 7 days. The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting reflux, abdominal pain, indigestion, diarrhea and constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The effect of the interventions on the GSRS will be assessed by a linear mixed model and will take into account information on this from all 7 days of treatment.
次要结局
- Stool consistency(Throughout 7 days of treatment)
- Stool frequency(Throughout 7 days of treatment)