Modulation of the Gut Microbiota and Metabolism in Elderly by Algae Products.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- frailty status
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 65 years or older
- •Independent in activities of daily living
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: Fermented Black Soybean and Adlay Supplement (Dietary Supplement)
Outcomes
Primary Outcomes
frailty status
Time Frame: 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.
Secondary Outcomes
- 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)