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

NCT06882941 | Completed

• 1 other identifier: 201804003RINB
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

frailty; Black soybean; Adlay; fermentation; gut microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Non-Fermented Black Soybean and Adlay Supplement

PLACEBO COMPARATOR

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

Fermented Black Soybean and Adlay Supplement

EXPERIMENTAL

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

Interventions

Fermented Black Soybean and Adlay Supplement DIETARY_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.

Fermented Black Soybean and Adlay Supplement

non-fermented black soybean and adlay supplement DIETARY_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.

Non-Fermented Black Soybean and Adlay Supplement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Independent in activities of daily living

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parcitipants will be stratified randomization into placebo and experimental groups based on their robustness status.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: March 19, 2025
• Study Start: December 12, 2018
• Primary Completion: December 17, 2020
• Study Completion: April 16, 2021
• Last Updated: March 19, 2025

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)