NCT03668964已完成不适用
A Randomized, Double-blinded, Parallel, Placebo-controlled Pilot Study to Investigate the Effect of Nutrition Ingredients on Microbiota Composition in Healthy Adults
DSM Nutritional Products, Inc.2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2018年8月20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
- 96
- 试验地点
- 2
- 主要终点
- Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing
研究概览
简要总结
The objective of this study is to evaluate in healthy volunteers the time-dependent effect of daily consumption for four weeks of six different nutrition ingredients on relative abundance of microbial taxa in fecal samples. Second, the study looks at the time-dependent effect of six different nutrition ingredients on alpha and beta diversity of microbiota in fecal samples. Moreover, the time-dependent effect of six different nutrition ingredients on gastrointestinal symptoms and quality of life will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements;
- •Be between 20 and 50 years of age;
- •Has a BMI of between 18.5 - 30 Kg/m2;
- •Has a stable body weight (< 5% change) over the past 3-months;
- •Is in general good health, as determined by the investigator;
- •Willing to avoid consuming dietary supplements, prebiotic, probiotic, dietary or fibre rich supplements within 4 weeks prior to baseline visit, until the end of the study;
- •Willing to avoid liver consumption during the intervention
- •Maintain current level of physical activity;
- •Women of child-bearing potential using a non-hormonal contraceptive (e.g. IUD);
- •Willing to consume the investigational product daily for the duration of the study.
排除标准
- •Females are pregnant, lactating or wish to become pregnant during the study.
- •Are hypersensitive to any of the components of the test product;
- •Has taken antibiotics within the previous 3 months;
- •Has a history of drug and/or alcohol abuse at the time of enrolment;
- •Consumes greater than 2 servings/day of alcohol (e.g. >28 g ethanol/day);
- •Is a smoker;
- •Has made any major dietary changes in the past 3 months;
- •Subject is planning a sun or ski holiday over the duration of the study;
- •Planned major changes in life style (i.e. diet, dieting, exercise level, travelling) during the duration of the study;
- •Has an eating disorder;
- •Is vegetarian/vegan diet or has food allergies or other issues with foods that would preclude intake of the study products;
- •Is using fibre supplements or enemas;
- •Has a high fiber diet (i.e. >30 g) based on FFQ;
- •Has an active gastrointestinal disorder or previous gastrointestinal surgery,
- •If taking chronic medications (e.g., anti-hypertensive medications), they must have been taking the product for at least two months prior to screening and agree to maintain the same dosage throughout the study;
- •Has a metabolic, psychiatric, or gastrointestinal disease (i.e., diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, diabetes, hepatitis, HIV, cancer, etc.), with a history of such diseases;
- •Are severely immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy within the last year);
- •Experiences alarm features such as weight loss, rectal bleeding, recent change in bowel habit (<3 months) or abdominal pain;
- •Have a malignant disease or any concomitant end-stage organ disease;
- •Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial;
- •Subjects may not be receiving treatment involving experimental drugs. If the subject has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
结局指标
主要结局
Relative abundance of microbial taxa in fecal samples as assessed by shotgun profiling based on shotgun sequencing
时间窗: from baseline to 4 weeks
Changes from baseline in the treatment groups as compared to placebo of relative abundance of microbial taxa (operational taxonomic units)
次要结局
- Cytokines and chemokines in blood(from baseline to 4 weeks)
- Beta diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing(from baseline to 4 weeks)
- Ammonia concentrations in fecal samples(from baseline to 4 weeks)
- Alpha diversity of microbiota in fecal samples as assessed by shotgun profiling based on shotgun sequencing(from baseline to 4 weeks)
- Short-chain fatty acids concentrations in fecal samples(from baseline to 4 weeks)
研究者
研究点 (2)
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