NCT06646458已完成不适用
Xuanwu Pilot: A Prospective, Interventional, Single-arm, Before-and-after Explorative Pilot to Gain Insights on Gastrointestinal and Related Benefits of the New Senior Milk Powder
Danone Nutricia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gastrointestinal (GI) function Questionnaire
研究概览
简要总结
The purpose of this interventional, single-arm pilot study aimed to evaluate the new product that newly developed contains a mixture of prebiotics and probiotics to gain insights of GI function acceptance, microbiological composition and related benefits before and after study product consumption in population aged between 50-70 years.
This project also serves the purpose of formulating conceptual hypothesis and directions of exploration for future research.
The main questions it aims to answer are:
- Microbiological change from stool samples collected at baseline and in the days after study product usage
- Gastrointestinal function and acceptance assessed during the study period
- Health related outcomes assessed via wearable device
- Any safety events
No comparison group
Participants will:
- Take study product
- Visit the study site
- Collect the stool sample
- Record daily gastrointestinal tolerance and health data
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age 50-70 years (bounds included)
- •Body Mass Index (BMI) between 18.5 (bound included) and 30 (bound excluded) kg/m
- •Ability to comply with the protocol and assessment window:
- •Product intake according to instructions.
- •Willing to collect, store, deliver stool sample according to instructions.
- •Willing to adhere to instructions and restrictions during entire study period*:
- •No probiotic supplementations or products supplemented with probiotics.
- •No dietary fiber supplements.
- •No medications may modify gastrointestinal function.
- •Fluency in speaking, reading and writing in mandarin.
- •Capability of the subject to install and use the secure study platform on the smartphone during entire study period.
- •Written informed consent. *Overruled in case of medical needs.
排除标准
- •• Known / Existing gastrointestinal diseases or disorders diagnosed by a physician that may interfere with study.
- •Known / Existing milk protein allergies, lactose intolerance or other allergies to product ingredients.
- •Known / Existing immune diseases or disorders diagnosed by a physician that may interfere with study.
- •Use of any medication may modify gastrointestinal function: tricyclic antidepressants, SSRIs/antidepressants, opioids, ACE inhibitor, bate sympathomimetics, systemic antibiotics, intestinal antiseptics, anti-inflammatory medicines (including nonsteroidal anti-inflammatory drugs [NSAIDs] and aspirin), anti-histamines, steroids, corticosteroids, laxatives, anti-diarrhoea medication, prokinetics/dopamine-antagonists, metformin, statins, or any other stomach medication (including proton pump inhibitor [PPIs], antiacids, and antihistamine2 blockers) within 8 weeks prior to enrolment.
- •Consumption of probiotic supplementations or products supplemented with probiotics within 4 weeks prior to enrolment.
- •Subject following a special diet, including but not limited to vegan diet, ketogenic diet, low fiber diet, thickening diet etc.
- •Incapability to comply with protocol as per the judgement of the investigator.
- •Participation in any other studies involving investigational or marketed products concomitantly or 2 weeks prior to enrolment.
- •Employees and/or children/family member or relatives of employees of Danone or the participating site.
研究组 & 干预措施
Milk Powder (study product) usage group
Experimental
Investigational Product Participants in this arm will need to take 2 times every day from baseline visit to 28 days.
干预措施: Healthy Elderly Volunteers (Other)
结局指标
主要结局
Gastrointestinal (GI) function Questionnaire
时间窗: from baseline (0 day) to the end of treatment at 28 days
Gastrointestinal symptoms assessed the tolerance of product via the Incidence of gastrointestinal discomfort
次要结局
- Microbiological analysis(from baseline to the end of study at 28 days)
研究者
研究点 (1)
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