Clinical trial NCT04951843: Koji Product Supplementation' s Study
Official title: The Effect of Black Soybeans Koji Product Supplementation on Nutrients Absorption and Anti-aging Effect in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: protein
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
name: Taipei Medical University
First posted: 2021-07-07
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body mass index
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Fat mass
timeFrame: Change from baseline outcome measure at 10th week (post-test).
measure: Muscle mas
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Visceral fat area(VFA)
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: BIA - Basal Metabolic Rate(BMR)
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: whole body Mineral
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Bone Mineral Content
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Cellular Water
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Muscle Strength - Hand Grip Strength
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Physical Performance - Walking Speed
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Gut Microbiota Composition Analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Gut Microbiota -derived Metabolite Analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Inflammatory Cytokines TNF-α Analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Inflammatory Cytokines IL-6 Analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Inflammatory Cytokines IL-1β Analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Red blood cells analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Hemoglobin analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: MCHC(g/dL) analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Albumin analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Hematocrit analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: RDW-CV analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: HbA1C analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: MCV analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: MCH analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Platelets analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: WBC analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: AST analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: ALT analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: GGT analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: T-Cholesterol analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Triglyceride analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: BUN analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Uric acid analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: HDL-C analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: LDL-C analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: hs-CRP analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Fasting blood glucose analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Creatinine analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Free T4 analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: hsTSH analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: HOMA-IR analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Insulin analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: eGFR analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Ca analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: specific gravity index analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Urine pH analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Urine total protein analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Urine glucose analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Urine Urea Nitrogen analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Urine ketones analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Urine Creatinine analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Urine bilirubin (dipstick) analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Urine Albumin analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Urine Albumin/Creatinine analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Urine Nitrite (dipstick) analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Urine WBC esterase analysis
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Superoxide dismutase (SOD) Oxidative stress assessment
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Glutathione peroxidase (GPx) Oxidative stress assessment
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Catalase Oxidative stress assessment
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Physical examination-Height
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Physical examination- Body weight
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Physical examination - waist circumference
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Physical examination - arm circumference
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Physical examination - calf circumference
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Physical examination - hip circumference
timeFrame: Change from baseline outcome measure at 10th week (post-test)
Secondary outcomes:
measure: Physical Activity Questionnaire assessment
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: 24-hour Dietary Recall Form
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Gastrointestinal Function Assessment
timeFrame: Change from baseline outcome measure at 10th week (post-test)
measure: Mini nutrition assessment
timeFrame: Change from baseline outcome measure at 10th week (post-test)
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Taipei Medical University
Study officials:
affiliation: Taipei Medical University Graduate Institute of Metabolism and Obesity Sciences
name: Hui-Yu Huang, Ph.D
role: STUDY_CHAIR
References: