NCT05803811已完成不适用
Effect of Colon Delivered Vitamin B2 on Gut Microbiota and Related Health Biomarkers in Healthy Older Adults
dsm-firmenich Switzerland AG1 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2022年12月12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
- 348
- 试验地点
- 1
- 主要终点
- Faecal microbial composition and diversity
研究概览
简要总结
The goal of this intervention study (clinical trial) is to investigate the effect of colon-delivered Riboflavin (vitamin B2) on the faecal microbial composition and diversity in older healthy subjects (50 -70 years of age)
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be willing and able to give written informed consent and to understand, to participate, and to comply with the clinical study requirements.
- •Between 50 and 70 years of age.
- •Has a BMI of between 18.5 - 30 Kg/m
- •Participants have had a stable body weight (≤5 % change) over the past 3-months.
- •Is in general good health, as determined by interview and vital signs (blood pressure, heart rate, pulse) by the investigator.
- •Willing to avoid consuming gut microbiome modulating dietary supplements, prebiotic, probiotic, or fibre-rich supplements, and, within 4 weeks prior to the baseline visit, until the end of the study.
- •Maintain current level of physical activity.
- •Willing to consume the investigational product daily for the duration of the study.
- •Female participants in menopause for at least the last one year. -
排除标准
- •Are hypersensitive to any of the components of the test product.
- •Has taken antibiotics within the previous 3 months prior to Baseline (Visit2)
- •Is currently using systemic steroids, systemic antibiotics, proton pump inhibitors, H2 blocker, antacid, metformin, or immunosuppressant medication.
- •Participant has a history of drug and/or alcohol abuse at the time of enrolment (Drinks more than nationally recommended units per week (>11 units for women; >17 units for men); Is currently in treatment for alcohol/substance abuse; Has been diagnosed with alcohol/substance abuse disorder).
- •Is a smoker or vaper.
- •Vegetarian or vegan.
- •Has made any major dietary changes in the past 3 months prior to Baseline (Visit 2).
- •Planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.
- •Has a currently active eating disorder.
- •Has food allergies or other issues with foods that would preclude the intake of the study products, as determined by the study investigator.
- •Is having a typical fibre intake >30 g fibre/day.
- •Has an active gastrointestinal disorder or previous gastrointestinal surgery, which in the opinion of the investigator would impact the study outcomes.
- •If taking chronic medications (e.g., anti-hypertensive medications), they must have been taking the product for at least two months to screening and agree to maintain the same dosage throughout the study.
- •Has severe or uncontrolled type 2 diabetes, psychiatric disorder, gastrointestinal disease (i.e., diarrhoea, Crohn's disease, ulcerative colitis, IBS, diverticulosis, stomach or duodenal ulcers respiratory or cardiac illness or any other condition which in the opinion of the investigator would impact the study outcomes.
- •Has a current or history of any gastrointestinal cancer
- •Are severely immunocompromised (HIV positive, transplant patient, on anti-rejection medications, on a steroid for >30 days, or chemotherapy or radiotherapy with the last year).
- •Experiences alarm features such as weight loss, rectal bleeding, a recent change in bowel habit (<3 months).
- •Have a current 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.
- •Participants may not be receiving treatment involving experimental drugs. If the participant has been in a recent experimental trial, these must have been completed not less than 60 days prior to this study.
- •Participants who have undergone intensive skin treatments (e.g. laser treatment or skin related surgery) in the last 3 months.
- •If taking any dietary supplements or medications known to affect skin health or other trial measures (resveratrol, ginkgo biloba, ginseng, fruit powder extracts and DHA).
- •Has a skin condition likely to interfere with skin assessments (e.g., eczema, dermatitis, any open skin wounds, reactive and sensitive skin).
结局指标
主要结局
Faecal microbial composition and diversity
时间窗: from baseline to 12 weeks
To assess the changes of faecal microbial composition and diversity from baseline to 12 weeks supplementation of three different doses of colon delivered vitamin B2 to compare the changes to placebo. levels, and alpha and beta diversity indices at the genus and species level as measured by metagenomic based profiles at baseline and at week 12
次要结局
- Intestinal barrier integrity(from baseline to 12 weeks)
- Gastrointestinal symptoms(from baseline to 12 weeks)
- health-related quality of life(from baseline to 12 weeks)
- Stool consistency(from baseline to 12 weeks)
- Stool frequency(from baseline to 12 weeks)
- Intestinal inflammation(from baseline to 12 weeks)
- Systemic vitamin status(from baseline to 12 weeks)
- Faecal microbial composition and diversity at week 4(from baseline to 4 weeks)
- Oxidative stress in blood(from baseline to 12 weeks)
- Faecal physiological pH(from baseline to 12 weeks)
- Faecal microbial metabolites fatty acid content at baseline and week 12(Intestinal inflammation as assessed by faecal calprotectin at baseline and at week 12)
- Inflammatory status in blood(from baseline to 12 weeks)
- Microbial metabolites at week 4(from baseline to 4 weeks)
研究者
研究点 (1)
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