Modulation of the Gut Microbiota and Metabolism in Elderly by Algae Products.
NCT06882941 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141
Last updated 2025-03-19
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.
Conditions
Interventions
- 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.
- DIETARY_SUPPLEMENT
-
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.
Sponsors & Collaborators
-
National Taiwan University Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-12-12
- Primary Completion
- 2020-12-17
- Completion
- 2021-04-16
Countries
- Taiwan
Study Locations
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