NCT07093463招募中不适用
The Benefit of Colon-delivered Riboflavin (Riboflavin-cd) vs. Conventional Riboflavin on Gut Microbiota Composition and Metabolic Output in Healthy Aging Subjects - a Pilot Proof of Concept Study
DSM Nutritional Products, Inc.2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年7月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Microbial alpha diversity
研究概览
简要总结
Recent studies suggest B-vitamins such as riboflavin to possess prebiotic-like effects. However, there is still a lack of understanding of the exact host health benefits vs. conventional systemically available vitamin forms. The present study explores the benefit of colon-delivered vitamin B2 vs. conventional vitamin B2 in comparison to placebo in an aging population on gut microbiota and metabolic activity as well as gut health.
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
- •Individuals providing written informed consent for participation in the study and data processing
- •Female and males between 50 and 70 years of age
- •For females only: Menopausal as marked by at least 1 year since the last menstrual bleeding
- •Individuals with a BMI between 18.5 - 29.9 Kg/m2
- •Individuals with stable body weight (≤5% change) over the past 3 months prior to V1
- •Individuals with self-reported moderate bowel complaints in at least last 3 months prior to V1
- •Individuals with GSRS score suggestive of moderate bowel complaints, as assessed at V1, for the average condition over the 4 last weeks (all GSRS items have to be answered at V1): • indigestion score 3-5 or constipation score 3-5 or diarrhoea score 3-5
- •Individuals with a general good health, as determined by questioning, clinical examination and vital signs (blood pressure, pulse rate) by the investigator at V1
- •Individuals willing to avoid consuming gut microbiome modulating dietary supplements, prebiotic, probiotic, synbiotic or fibre-rich supplements during the entire study duration
- •Individuals willing to maintain current level of physical activity throughout the entire study duration
- •If individuals are taking chronic medications (e.g., antihypertensive medications), they must be willing and expected to maintain the same dosage throughout the study
排除标准
- •Individuals who are hypersensitive/intolerant to any of the components of the Investigational product or the standardised diet addition (inulin)
- •Individuals who have taken systemic antibiotics within the previous 3 months prior to Baseline (V2) or are expected to be taking any during the study
- •Individuals who consumed microbiome modulating dietary supplements, prebiotic, probiotic, or fibre-rich supplements within 4 weeks prior to the baseline (V2)
- •Individuals who are currently regularly using systemic steroids, proton pump inhibitors, H2 blocker, antacids (however, sporadic use during the study if needed is allowed, but not within 8 hours before each visit), metformin if started less than 6 months prior to V1, or immunosuppressant medication.
- •Individuals who have a history of drug abuse in the previous 5 years and/or alcohol abuse at the time of enrolment (>11 units/week for women; >17 units/week for men; unit: approx. 125 mL of wine or similar / approx. 30 mL of spirits
- •/ approx. 280 mL beer or similar); Is currently in treatment for alcohol/substance abuse; Has been diagnosed with alcohol/substance abuse disorder)
- •Individuals who are a smoker or vaper
- •Individuals who are vegetarian or vegan
- •Individuals who have made any major dietary changes in the past 3 months prior to Baseline (V2)
- •Individuals who have planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.
- •Individuals who have a currently present active eating disorder
- •Individuals with self-reported food allergy / intolerance (e.g., lactose, gluten, fructose), as determined by the study investigator
- •Clinical significance for any of screening laboratory test results from the blood draw at V1, as per investigator's judgement
- •Individuals with a self-reported fibre-rich regular diet, as per investigator's judgement
- •Individuals who have a (self-reported) gastrointestinal disorder/disease (e.g., chronic/recurrent diarrhoea, inflammatory bowel disorder, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, bile acid malabsorption) or previous gastrointestinal surgery (such as bariatric surgery, colon specific surgical interventions etc.), which in the opinion of the investigator would impact the study outcomes
- •Individuals with GSRS assessed at V1 for the average condition over the 4 last weeks prior to V1 for any score (abdominal pain, reflux score, indigestion, constipation, diarrhoea) >5 (all GSRS items have to be answered at V1)
- •Individuals who have severe or uncontrolled conditions such as type 2 diabetes (FBG ≥ 150 mg/dl from blood draw at V1), psychiatric disorder, respiratory or cardiac illness or any other condition which in the opinion of the investigator would impact the study outcomes
- •Individuals who have a history of any gastrointestinal cancer
- •Individuals who are severely immunocompromised
- •Individuals with alarm features in the past 3 months prior to V1 such as unintentional weight loss (≤5% change), fever, anorectal problems, blood in stool, vomiting
- •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 study requirements
- •If Individuals have been in a recent experimental study, this must have been completed not less than 30 days prior to this study
结局指标
主要结局
Microbial alpha diversity
时间窗: 4 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd)
Variation D28 - D0 in the faecal microbial alpha diversity (Observed richness, Inverse Simpson index, Shannon index)
次要结局
- Faecal organic acid(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
- Stool consistency and frequency(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
- Microbial composition(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
- Fecal redox potential(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
- Fecal calprotectin(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
- Plasma Intestinal barrier markers(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
- Quality of life (Short-Form Health Survey (SF-36))(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
- Faecal riboflavin(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
- fecal pH(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
- Microbial alpha diversity(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
- Gastrointestinal complaints(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
- Investigational product (IP) perceived benefit(8 weeks' daily consumption of 10 mg of colon delivered riboflavin (riboflavin-cd) including 5 g of dietary fiber inulin per day as a standardised addition to the subjects daily diet from week 4 to week 8.)
研究者
研究点 (2)
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