NCT07846254招募中不适用
The Effects of Daily Supplementation of NUTRIOSE® on the Fecal Microbiota in Healthy Adult Volunteers Over 4 Weeks: a Randomized, Double-blinded, Placebo-controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Relative abundance of Parabacteroides genus
研究概览
简要总结
The effects of daily supplementation with NUTRIOSE® on the fecal microbiota. The study aims to evaluate the ability of NUTRIOSE® to support a beneficial modulation of the intestinal microbiota in healthy volunteers, compared with a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women aged ≥ 18 and ≤ 60 years;
- •Body mass index (BMI) ≥ 18 and ≤ 30 kg/m²;
- •With a usual normal intestinal transit (according to BSS). According to stool questionnaire completed between V0 and V1, mean of the 7 days of completion, maximum 3 stools / day and 3 stools/week minimum and with mean normal consistency
- •Good general and mental health according to the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination;
- •Agreement to maintain lifestyle habits during the study (same dietary and physical habits);
- •Able and willing to participate in the study by complying with the protocol procedures as evidenced by a dated and signed informed consent form (ICF);
- •Affiliated with a social security scheme;
排除标准
- •Suffering from a metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder;
- •Suffering from gastrointestinal disorders such as celiac disease, Crohn's disease, functional constipation, irritable bowel syndrome or another gastrointestinal found to be inconsistent with the study according to the investigator;
- •Suffering from a severe chronic disease (e.g. cancer, HIV, renal failure, hepatic or biliary disorders ongoing, uncontrolled cardiac disease, chronic inflammatory digestive disease, arthritis or other chronic respiratory trouble, etc.) or another severe disorders found to be inconsistent with the conduct of the study by the investigator;
- •With a known food allergy or intolerance or hypersensitivity to any ingredient of the IP;
- •Pregnant or lactating women or intending to become pregnant within 6 months ahead;
- •Having undergone recent surgical procedure in the past 6 months or planned on the 2 months to come;
- •Under treatment which could significantly affect parameter(s) followed during the study according to the investigator or stopped less than 4 weeks before the V0 visit, i.e. medication with impact on intestinal transit such as anti-diarrheal, anti-spasmodic,antidepressants antibiotics, antacids, laxative, antifungal, NSAI, anti-vomiting, GLP-1 receptor agonists, corticoids, opioids, narcotic analgesic and biliary acids chelator, and chronic hormonal treatment started less than 3 months ago (i.e. new method of hormonal contraception, thyroidal trouble treatment);
- •Regular intake of dietary supplements or "health foods", or products known to impact intestinal microbiota, containing or rich in prebiotics, probiotics, symbiotic, fibre, fermented milk or yogurt, kefir, ultra-yeast, vitamins and minerals, or stopped less than 3 months before the inclusion visit.
- •With significant change in dietary or physical activity habits in the 3 months before randomization (no hyper or hypocaloric diet, no high-protein diet, no prolonged fasting for more than one week, no planned change in the level of sports activity in the next 3 months);
- •Taking part in another clinical study or being in the exclusion period of a previous clinical study;
- •Under legal protection (guardianship, wardship) or deprived of his rights following the administrative or judicial decision;
- •Presenting psychological or linguistic incapability to sign the ICF;
- •Impossible to contact in case of emergency.
研究组 & 干预措施
NUTRIOSE® soluble fiber
Active Comparator
1 sachet to be taken at breakfast during 4 weeks
干预措施: NUTRIOSE® (Dietary Supplement)
GLUCIDEX® IT19 maltodextrin
Placebo Comparator
1 sachet to be taken at breakfast during 4 weeks
干预措施: Active comparator (Dietary Supplement)
结局指标
主要结局
Relative abundance of Parabacteroides genus
时间窗: After 4-week consumption
Relative abundance of Parabacteroides genus (assessed via shotgun metagenomics)
次要结局
- Comparisons at V2 of relative abundance of intestinal microbiota: Relative abundance of Bacteroides genus, Species (formerly defined as Clostridium Cluster IV and XIV), Bacillota phylum, Overall composition at the taxonomic level(After 4-week consumption)
- Comparisons at V2 of bowel movements: stool frequency(After 4-week consumption)
- Comparisons at V2 of bowel movements: stool consistency(After 4-week consumption)
- Comparisons at V2 of digestive well-being and bowel transit(after 4-week consumption)
- Occurrence of adverse events (AEs) and especially gastrointestinal AEs(after 4-weeks consumption)
研究者
研究点 (1)
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