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

National Taiwan University

Status: Completed

Conditions: Frailty

Treatments: Dietary Supplement: Fermented Black Soybean and Adlay Supplement; Dietary Supplement: non-fermented black soybean and adlay supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT06882941

201804003RINB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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141 participants in 2 patient groups, including a placebo group

Non-Fermented Black Soybean and Adlay Supplement

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: non-fermented black soybean and adlay supplement

Fermented Black Soybean and Adlay Supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fermented Black Soybean and Adlay Supplement