Koji Product Supplementation’ s Study

Overview

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 Title of Study: “The Effect of Black Soybeans Koji Product Supplementation on Nutrients Absorption and Anti-aging Effect in Elderly”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2020

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.

Interventions

  • Dietary Supplement: Black soybean koji product
    • Black soybean koji product

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Body mass index
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure Participants’ detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure body mass index (BMI).
  • Fat mass
    • Time Frame: Change from baseline outcome measure at 10th week (post-test).
    • Measure Participants’ detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure fat mass.
  • Muscle mas
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure Participants’ detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure whole body and appendicular skeletal muscle mass.
  • Visceral fat area(VFA)
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure Participants’ detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Visceral fat area(VFA) (cm2).
  • BIA – Basal Metabolic Rate(BMR)
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure Participants’ detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Basal Metabolic Rate(BMR) (kcal) .
  • whole body Mineral
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure Participants’ detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Mineral (kg) in whole body. .
  • Bone Mineral Content
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure Participants’ detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Bone Mineral Content (kg).
  • Cellular Water
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure Participants’ detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure whole body Extracellular Water (L), Intracellular Water(L), and Total Body Water (L), et al. .
  • Muscle Strength – Hand Grip Strength
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Using hand grips to measure hand grip strength.
  • Physical Performance – Walking Speed
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measuring participants’ speed to walk 5 ft.
  • Gut Microbiota Composition Analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Total genome DNA from samples was extracted from stool samples using the CTAB/SDS method. One hundred ng of DNA was amplified with barcoded primers16S V3+V4: 314F-806R annealing to the V3-V4region of the 16S rRNA. All of the PCR reactions were carried out using a Phusion® High-Fidelity PCR Master Mix (New England Biolabs, Location). Samples with a bright main strip between 400 and 450bp were selected from 2% agarose gel for further experiments. Mixture PCR products were purified using a Qiagen Gel Extraction Kit (Qiagen, Germany). Libraries were generated with the TruSeq® DNA PCR-Free Sample Preparation Kit and quantified with Qubit and Q-PCR. The purified DNA was then sequenced using the HiSeq2500 PE250 (Company, Location).
  • Gut Microbiota -derived Metabolite Analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measurements of short-chain fatty acids in feces during the experiment by using gas chromatography.
  • Inflammatory Cytokines TNF-α Analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • The inflammation-associated serum cytokines TNF-α was analyzed using colorimetric kits (Company, Location). Thioredoxin (Cloud-Clone Corp, SEA702Hu, City, State, USA) and Complement Component 5a (Cloud-Clone Corp, SEA388Hu) in the urine was evaluated for the effects of inflammation states and also assessed using colorimetric kits. The procedures followed the kit instructions and were measured using an ELISA reader (Bio Tek, PowerWave XS2, City, State, USA).
  • Inflammatory Cytokines IL-6 Analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • The inflammation-associated serum cytokines IL-6 was analyzed using colorimetric kits (Company, Location). Thioredoxin (Cloud-Clone Corp, SEA702Hu, City, State, USA) and Complement Component 5a (Cloud-Clone Corp, SEA388Hu) in the urine was evaluated for the effects of inflammation states and also assessed using colorimetric kits. The procedures followed the kit instructions and were measured using an ELISA reader (Bio Tek, PowerWave XS2, City, State, USA).
  • Inflammatory Cytokines IL-1β Analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • The inflammation-associated serum cytokines IL-1β (BioLegend, City, State, USA) was analyzed using colorimetric kits (Company, Location). Thioredoxin (Cloud-Clone Corp, SEA702Hu, City, State, USA) and Complement Component 5a (Cloud-Clone Corp, SEA388Hu) in the urine was evaluated for the effects of inflammation states and also assessed using colorimetric kits. The procedures followed the kit instructions and were measured using an ELISA reader (Bio Tek, PowerWave XS2, City, State, USA).
  • Red blood cells analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of red blood cells( M/ul)
  • Hemoglobin analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of Hemoglobin(g/dL).
  • MCHC(g/dL) analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of MCHC(g/dL)
  • Albumin analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of albumin(g/dL).
  • Hematocrit analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of Hematocrit(%).
  • RDW-CV analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of RDW-CV(%).
  • HbA1C analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of HbA1C(%).
  • MCV analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of MCV(fL).
  • MCH analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of MCH(pg).
  • Platelets analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of Platelets(k/uL).
  • WBC analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of WBC(k/uL) .
  • AST analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of AST(U/L).
  • ALT analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of ALT(U/L).
  • GGT analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of GGT(U/L).
  • T-Cholesterol analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of T-Cholesterol(mg/dL).
  • Triglyceride analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of triglyceride(mg/dL).
  • BUN analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of BUN(mg/dL).
  • Uric acid analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of Uric acid(mg/dL).
  • HDL-C analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of HDL-C(mg/dL).
  • LDL-C analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of LDL-C(mg/dL).
  • hs-CRP analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of hs-CRP(mg/dL).
  • Fasting blood glucose analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of fasting blood glucose(mg/dL).
  • Creatinine analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of creatinine(mg/dL).
  • Free T4 analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of 【Free T4(ng/dL)】
  • hsTSH analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of 【hsTSH(ulU/dL)】
  • HOMA-IR analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of 【 HOMA-IR】
  • Insulin analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of 【 insulin(uU/dL)】
  • eGFR analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of 【eGFR (mL/min/1.73^2)】
  • Ca analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Use the Clinical Chemistry Analyzer to detection of Ca(mmol/dL).
  • specific gravity index analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes specific gravity index (USG).
  • Urine pH analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes pH.
  • Urine total protein analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Total protein (mg/dL).
  • Urine glucose analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes glucose (-/+).
  • Urine Urea Nitrogen analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Urine Urea Nitrogen(-/+).
  • Urine ketones analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes ketones(-/+).
  • Urine Creatinine analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Creatinine(mg/dL).
  • Urine bilirubin (dipstick) analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes bilirubin (-/+).
  • Urine Albumin analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Albumin(mg/L).
  • Urine Albumin/Creatinine analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Albumin/Creatinine(mg/g).
  • Urine Nitrite (dipstick) analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Nitrite(-/+).
  • Urine WBC esterase analysis
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes WBC esterase(-/+).
  • Superoxide dismutase (SOD) Oxidative stress assessment
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Oxidative stress assessment to assess Superoxide dismutase (SOD) in serum was measured by the ELISA kit.
  • Glutathione peroxidase (GPx) Oxidative stress assessment
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Oxidative stress assessment to assess Glutathione peroxidase (GPx) in serum was measured by the ELISA kit..
  • Catalase Oxidative stress assessment
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Oxidative stress assessment to assess Catalase in serum was measured by the ELISA kit..
  • Physical examination-Height
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure participants’ height. The height measurement method is to measure after you take off your shoes and step on the machine.
  • Physical examination- Body weight
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure participants’ body weight. The body weight measurement method is to measure after you take off your shoes and step on the weight machine.
  • Physical examination – waist circumference
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure participants’ waist circumference. The waist measurement method is to use a tape measure to measure the waist circumference above the human hips.
  • Physical examination – arm circumference
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure participants’ arm circumference. The measurement method of the arm circumference is the circumference of the upper arm and is measured at the mid-point between the tips of the shoulder and elbow. .
  • Physical examination – calf circumference
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure participants’ calf circumference. The measurement method of the calf circumference should be the same as the shoulder width and place the tape measure at the thickest part of the calf with a horizontal line around it for measurement.
  • Physical examination – hip circumference
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Measure participants’ hip circumference. The hip measurement method is to use a tape measure to measure the maximum hip diameter.

Secondary Measures

  • Physical Activity Questionnaire assessment
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Using Physical Activity Questionnaire to assess participants’ activity level.
  • 24-hour Dietary Recall Form
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • The 24-hour diet recall method is conducted by interviewers who have received professional training in food serving size. Ask participants to recall all food and beverages actually consumed in the past 24 hours and record them in the questionnaire. Location, and the name, material, quantity and preparation method of food; among them, the estimation of the quantity can be assisted by using food weighing tools and food quantitative aids.
  • Gastrointestinal Function Assessment
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • Assess the number of bowel movements, bowel habits, bowel pattern, and flatulence
  • Mini nutrition assessment
    • Time Frame: Change from baseline outcome measure at 10th week (post-test)
    • This Mini nutrition assessment is a Indicator of nutrition status .The score range from 0-30,24 to 30 points represent Normal nutritional status, 17 to 23.5 points represent At the risk of malnutrition, less than 17 points represent Malnourished.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • National Taiwan University Hospital
  • Collaborator
    • Ministry of Science and Technology, Taiwan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hui-Yu Huang, Ph.D, Study Chair, Taipei Medical University Graduate Institute of Metabolism and Obesity Sciences

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.