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Completed

NCT Number: NCT06882941

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.

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Key information

Conditions

Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. frailty status

    Time frame: 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 outcomes

  1. gut microbiota

    Time frame: 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.

  2. Physical performance: 5-meter walk speed

    Time frame: 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.

  3. physical performance: Timed Up and Go test

    Time frame: 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.

  4. physical performance: 30-second chair stand test

    Time frame: 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.

  5. physical performance: grip strength

    Time frame: 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.

  6. Number of participants with biochemistry blood tests.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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