Clinical trial NCT06882941: Modulation of the Gut Microbiota and Metabolism in Elderly by Algae Products.
Official title: Modulation of the Gut Microbiota and Metabolism in Elderly by Algae Products.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: frailty
Black soybean
Adlay
fermentation
gut microbiota
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 141
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parcitipants will be stratified randomization into placebo and experimental groups based on their robustness status.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: frailty status
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: gut microbiota
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Physical performance: 5-meter walk speed
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: physical performance: Timed Up and Go test
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: physical performance: 30-second chair stand test
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: physical performance: grip strength
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: Number of participants with biochemistry blood tests.
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: