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

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.

Study Overview

• Status: Completed
• Conditions: Frailty
• Intervention / Treatment: Dietary supplement: non-fermented black soybean and adlay supplement; Dietary supplement: Fermented Black Soybean and Adlay Supplement

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 Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	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.
Experimental: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frailty status	Frailty status will be assessed using modified Fried's criteria before and after consuming the product.	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gut microbiota	Gut microbiota will be analyzed via fecal sample collection before and after consuming the product.	From enrollment to the end of treatment at 12 weeks
Physical performance: 5-meter walk speed	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.	From enrollment to the end of treatment at 12 weeks
physical performance: Timed Up and Go test	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.	From enrollment to the end of treatment at 12 weeks
physical performance: 30-second chair stand test	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.	From enrollment to the end of treatment at 12 weeks
physical performance: grip strength	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.	From enrollment to the end of treatment at 12 weeks
Number of participants with biochemistry blood tests.	Biochemical data from blood samples of the 141 participants will be analyzed before and after consuming the product.	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2018
• Primary Completion (Actual): December 17, 2020
• Study Completion (Actual): April 16, 2021

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: frailty; gut microbiota; fermentation; Black soybean; Adlay
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 201804003RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No