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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Parcitipants will be stratified randomization into placebo and experimental groups based on their robustness status.
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| 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. |
|
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 |