Modulation of the Gut Microbiota and Metabolism in Elderly by Algae Products.

Not Applicable

Completed

• Conditions: Frailty

• Registration Number: NCT06882941
• Lead Sponsor: National Taiwan University Hospital

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 Timeline

• Status Verified: 2018-05
• Study Start: 2018-12-12
• Primary Completion: 2020-12-17
• Study Completion: 2021-04-16
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-19
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
frailty status	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 Outcome Measures

Name	Time	Method
gut microbiota	From enrollment to the end of treatment at 12 weeks	Gut microbiota will be analyzed via fecal sample collection before and after consuming the product.
Physical performance: 5-meter walk speed	From enrollment to the end of treatment at 12 weeks	5-meter walk speed will be evaluated before and after consuming the product. The participant will be asked to walk at their normal comfortable pace until they reach the end of the 5-meter mark.
physical performance: Timed Up and Go test	From enrollment to the end of treatment at 12 weeks	Timed Up and Go test will be evaluated before and after consuming the product. The Timed Up and Go test measures functional mobility by timing a participant as they rise from a chair, walk 3 meters, turn around, walk back, and sit down.
physical performance: 30-second chair stand test	From enrollment to the end of treatment at 12 weeks	Thirty-second chair stand test will be evaluated before and after consuming the product.; The 30-Second Chair Stand Test measures lower body strength and endurance by counting the number of times a participant can fully stand up from a chair and sit back down within 30 seconds.
physical performance: grip strength	From enrollment to the end of treatment at 12 weeks	Grip strength will be measured before and after consuming the product. Grip strength measurement assesses upper body muscle strength by using a dynamometer to measure the maximum force exerted when a participant squeezes the device with their dominant hand.
Number of participants with biochemistry blood tests.	From enrollment to the end of treatment at 12 weeks	Biochemical data from blood samples of the 141 participants will be analyzed before and after consuming the product.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan