Koji Product Supplementation' s Study (KPS)

National Taiwan University

Status: Completed

Conditions: Sarcopenia

Treatments: Dietary Supplement: Black soybean koji product

Study type: Interventional

Funder types: Other

Identifiers

NCT04951843

201806058RINA

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Black soybean koji product

Experimental group

Description:

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

Treatment:

Dietary Supplement: Black soybean koji product