Modulation of the Gut Microbiota and Metabolism in Elderly by Algae Products.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- frailty status
研究概览
简要总结
The goal of this clinical trial is to determine whether a fermented black soybean and adlay supplement can improve frailty. The main questions it seeks to answer are:
- Does the fermented black soybean and adlay supplement improve physical performance?
- What is the effect of the fermented black soybean and adlay supplement on gut microbiota? Researchers will compare the fermented black soybean and adlay supplement to a placebo (a non-fermented black soybean and adlay supplement) to assess its impact on physical performance.
Participants will:
- Take either the fermented black soybean and adlay supplement or a placebo daily for 12 weeks.
- Visit the clinic for checkups and tests before and after consuming the product.
详细描述
This study aims to evaluate the effects of fermented black soybean and adlay supplements on frailty and gut microbiota in older adults. Older participants are recruited from National Taiwan University Hospital. Parcitipants will be stratified randomization into placebo and experimental groups based on their robustness status. Older participants will take either the fermented black soybean and adlay supplement or a placebo daily for 12 weeks. Baseline characteristics of the participants, including demographic data, chronic disease history, and anthropometric data, will be collected. Cognitive function will be evaluated using the Mini-Mental Status Examination. A 15-item version of the Geriatric Depression Scale will be used to identify depressive symptoms. Nutritional status will be assessed with the Mini Nutritional Assessment. Blood and fecal samples, as well as data on physical performance and frailty status, will be collected before and after consuming the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 years or older
- •Independent in activities of daily living
排除标准
- •Being bedridden or residing in a nursing home
- •Having a life expectancy of less than 6 months
- •Having severe hearing or communication disorders
- •Having hyperuricemia, gouty arthritis, or swallowing dysfunction
研究组 & 干预措施
Non-Fermented Black Soybean and Adlay Supplement
The placebo product was prepared using uninoculated autoclaved black soybean and dehulled adlay. The samples were provided as frozen food and required microwaving for 30 seconds before serving. Participants assigned to the placebo group will take the non-fermented black soybean and adlay supplement daily for 12 weeks.
干预措施: non-fermented black soybean and adlay supplement (Dietary Supplement)
Fermented Black Soybean and Adlay Supplement
The preparation of the fermented black soybean and adlay supplement involves autoclaved black soybean and dehulled adlay, which are inoculated with Bacillus subtilis natto (1.3 × 10⁶ CFU/g) and incubated for 43 hours at 28°C. Participants assigned to the experimental group will take the Fermented Black Soybean and Adlay Supplement daily for 12 weeks.
干预措施: Fermented Black Soybean and Adlay Supplement (Dietary Supplement)
结局指标
主要结局
frailty status
时间窗: From enrollment to the end of treatment at 12 weeks
Frailty status will be assessed using modified Fried's criteria before and after consuming the product.
次要结局
- gut microbiota(From enrollment to the end of treatment at 12 weeks)
- Physical performance: 5-meter walk speed(From enrollment to the end of treatment at 12 weeks)
- physical performance: Timed Up and Go test(From enrollment to the end of treatment at 12 weeks)
- physical performance: 30-second chair stand test(From enrollment to the end of treatment at 12 weeks)
- physical performance: grip strength(From enrollment to the end of treatment at 12 weeks)
- Number of participants with biochemistry blood tests.(From enrollment to the end of treatment at 12 weeks)