Koji Product Supplementation' s Study

NCT ID: NCT04951843

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-12

Study Completion Date

2020-06-30

Brief Summary

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The present project is to identify the effect of black soy beans Koji product supplementation on nutrients absorption and anti-aging effect in elderly.

Detailed Description

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Previous studies show that supplementation of soy protein can effectively increase muscle mass and protein utilization. Besides, soy extracts and isoflavones can stimulate muscle growth by activating the anabolic pathway of muscle tubules. Black soybean is known to be rich in legume protein and isoflavones.We speculate that black soybean supplementation can improve the nutritional status and muscle mass of elderly people, thereby delaying the deterioration of muscular dystrophy in the elderly. Reduce the occurrence of debilitation in the elderly.

Conditions

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Sarcopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Black soybean koji product

Oral supplement 2 servings of black soybean koji product per day, for 10 weeks.

Group Type EXPERIMENTAL

Black soybean koji product

Intervention Type DIETARY_SUPPLEMENT

Black soybean koji product

Interventions

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Black soybean koji product

Black soybean koji product

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 1-2 items are necessary, 3-5 can match one item

1. Age above 65 years
2. Oral intake
3. Walking speed: ≤ 0.8 m/s (measured by time for a 5-meter usual gait)
4. Handgrip strength: Men: \<26 kg Women: \<18 kg (measured by electronic hand grip dynamometer)
5. Calf circumference: Men: ≤ 34 cm Women: ≤ 33 cm

Exclusion Criteria

1. Participant in a moderate or strenuous exercise
2. Unable to walk
3. Unable to take in food from the mouth
4. People who can't record or communicate.
5. Refuse to accept the 3-day diet record
6. Allergic to black soybeans or legumes
7. Allergic to egg or milk
8. Infected with disease and had to be hospitalized for treatment before 4 weeks of the intervention test start
9. A patient who has been diagnosed with a malignant tumor or has a history of malignancy in the past year.
10. The estimated glomerular filtration rate (eGFR) is less than 60 ml/min/1.73 m2 in the past three months.
11. Hypothyroidism
12. People who often have symptoms of gastrointestinal upset.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Science and Technology, Taiwan

OTHER_GOV

Sponsor Role collaborator

Taipei Medical University

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hui-Yu Huang, Ph.D

Role: STUDY_CHAIR

Taipei Medical University Graduate Institute of Metabolism and Obesity Sciences

Locations

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Taipei Medical University

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201806058RINA

Identifier Type: -

Identifier Source: org_study_id

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