FrailtyNCT06882941
Modulation of the Gut Microbiota and Metabolism in Elderly by Algae Products.
A study testing Fermented Black Soybean and Adlay Supplement and non-fermented black soybean and adlay supplement in people with Frailty, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty
- What is being tested?
- Fermented Black Soybean and Adlay Supplement and non-fermented black soybean and adlay supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 141 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Dec 2018to 16 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years or older
- Independent in activities of daily living
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Frailty
- Being tested
- Fermented Black Soybean and Adlay Supplement, non-fermented black soybean and adlay supplement
- Keywords
- frailty, Black soybean, Adlay, fermentation, gut microbiota
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fermented Black Soybean and Adlay SupplementDietary 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 supplementDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Fermented Black Soybean and Adlay Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
frailty status
Frailty status will be assessed using modified Fried's criteria before and after consuming the product.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (6)
gut microbiota
Gut microbiota will be analyzed via fecal sample collection before and after consuming the product.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start12 Dec 2018
- Primary completion17 Dec 2020
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parcitipants will be stratified randomization into placebo and experimental groups based on their robustness status.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882941
- Sponsor's protocol ID
- 201804003RINB
- Status last verified
- May 2018
- First submitted
- 7 Jan 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of the Gut Microbiota and Metabolism in Elderly by Algae Products.
- ClinicalTrials.gov ID
- NCT06882941
- Acronym / sponsor ID
- 201804003RINB
- Conditions
- Frailty
- Keywords
- frailty, Black soybean, Adlay, fermentation, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parcitipants will be stratified randomization into placebo and experimental groups based on their robustness status.
| Arm | Type | Receives |
|---|---|---|
| Non-Fermented Black Soybean and Adlay Supplement | Placebo comparator | Dietary Supplement: non-fermented black soybean and adlay supplementThe 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. |
| Fermented Black Soybean and Adlay Supplement | Experimental | Dietary Supplement: Fermented Black Soybean and Adlay SupplementThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 65 years or older
- Independent in activities of daily living
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fermented Black Soybean and Adlay SupplementThe 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 |
| non-fermented black soybean and adlay supplementThe 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 |
Primary outcome
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.
6 secondary outcomes
gut microbiota
Time frame: From enrollment to the end of treatment at 12 weeks
Physical performance: 5-meter walk speed
Time frame: From enrollment to the end of treatment at 12 weeks
physical performance: Timed Up and Go test
Time frame: From enrollment to the end of treatment at 12 weeks
physical performance: 30-second chair stand test
Time frame: From enrollment to the end of treatment at 12 weeks
physical performance: grip strength
Time frame: From enrollment to the end of treatment at 12 weeks
Number of participants with biochemistry blood tests.
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fermented Black Soybean and Adlay Supplement and non-fermented black soybean and adlay supplement in people with Frailty, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frailty status (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.