NCT06115057已完成早期 1 期
The Investigation of Gastrointestinal Tolerance of a Novel Fibre Blend Among ≥45-<70-year-old Men and Women
Nutricia Research2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2023年10月4日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- GSRS change
研究概览
简要总结
Research shows that many people do not get enough dietary fiber through their normal diet. As a result, some nutrients are not properly absorbed into the bloodstream. The immune system however does need these nutrients. Dietary fibers are therefore important for health. Nutricia has developed a new blend of natural fibers that can help people get enough fiber.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 45 and ≤ 70 years
- •Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
- •Signed consent form
- •Willingness and ability to comply with the protocol
- •Good general health
- •Defecation frequency: between three bowel movements per week and three bowel movements per day within a month for screening.
排除标准
- •Presence or history of chronic gastrointestinal disorders (e.g. stomach ulcers, ulcerative colitis, Crohn's disease) or history of abdominal surgery with resection of the bowel (small or large intestine).
- •Presence of other medical conditions where gastrointestinal function often/probably is affected, such as:
- •autoimmune diseases (e.g. diabetes mellitus type I, multiple sclerosis, systemic lupus erythematosus).
- •eating disorders (e.g. anorexia nervosa, bulimia nervosa, binge eating disorder).
- •intestinal/gastrointestinal disorder due to a stroke.
- •Chronic diseases (including but not limited to hypertension, dyslipidaemia, type 2 diabetes mellitus, thyroid disorders) that cannot be controlled with the use of medication/therapy.
- •Severe acute liver disease or chronic liver disease.
- •Severe or chronic kidney disease or need for hemodialysis.
- •Colonoscopy, irrigoscopy or other bowel cleansing, or other surgical procedures related to the gastrointestinal tract (eg. colon polypectomy, appendectomy) or for which use of systemic antibiotics within 1 month before the screening is required or scheduled during participation in the study.
- •Use of enemas, laxatives, antacids, proton pump inhibitors, prokinetics (e.g. metoclopramide, drugs that affect motility), digestive enzymes, narcotic/morphine analgesics within 1 week prior to screening or intended use during participation in the study.
- •Following a vegetarian or vegan diet.
结局指标
主要结局
GSRS change
时间窗: 4 weeks
Change from baseline in the reported severity of GI symptoms assessed by the Gastrointestinal Symptom Rating Scale (GSRS) for diarrhea dimension at week 4 post-baseline.
次要结局
- GSRS change(week 1, week 2, week 3, week 4)
研究者
研究点 (2)
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