Koji Product Supplementation' s Study

Study Overview
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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.

Official Title
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The Effect of Black Soybeans Koji Product Supplementation on Nutrients Absorption and Anti-aging Effect in Elderly

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: Black soybean koji product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1-2 items are necessary, 3-5 can match one item Age above 65 years Oral intake Walking speed: ≤ 0.8 m/s (measured by time for a 5-meter usual gait) Handgrip strength: Men: <26 kg Women: <18 kg (measured by electronic hand grip dynamometer) Calf circumference: Men: ≤ 34 cm Women: ≤ 33 cm Exclusion Criteria: Participant in a moderate or strenuous exercise Unable to walk Unable to take in food from the mouth People who can't record or communicate. Refuse to accept the 3-day diet record Allergic to black soybeans or legumes Allergic to egg or milk Infected with disease and had to be hospitalized for treatment before 4 weeks of the intervention test start A patient who has been diagnosed with a malignant tumor or has a history of malignancy in the past year. The estimated glomerular filtration rate (eGFR) is less than 60 ml/min/1.73 m2 in the past three months. Hypothyroidism People who often have symptoms of gastrointestinal upset.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Black soybean koji product<br>Oral supplement 2 servings of black soybean koji product per day, for 10 weeks. | Dietary Supplement: Black soybean koji product<br>* Black soybean koji product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index | Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure body mass index (BMI). | Change from baseline outcome measure at 10th week (post-test) | 
| Fat mass | Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure fat mass. | Change from baseline outcome measure at 10th week (post-test). | 
| Muscle mas | 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. | Change from baseline outcome measure at 10th week (post-test) | 
| Visceral fat area(VFA) | Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Visceral fat area(VFA) (cm2). | Change from baseline outcome measure at 10th week (post-test) | 
| BIA - Basal Metabolic Rate(BMR) | Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Basal Metabolic Rate(BMR) (kcal) . | Change from baseline outcome measure at 10th week (post-test) | 
| whole body Mineral | Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Mineral (kg) in whole body. . | Change from baseline outcome measure at 10th week (post-test) | 
| Bone Mineral Content | Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Bone Mineral Content (kg). | Change from baseline outcome measure at 10th week (post-test) | 
| Cellular Water | 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. . | Change from baseline outcome measure at 10th week (post-test) | 
| Muscle Strength - Hand Grip Strength | Using hand grips to measure hand grip strength. | Change from baseline outcome measure at 10th week (post-test) | 
| Physical Performance - Walking Speed | Measuring participants' speed to walk 5 ft. | Change from baseline outcome measure at 10th week (post-test) | 
| Gut Microbiota Composition Analysis | 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). | Change from baseline outcome measure at 10th week (post-test) | 
| Gut Microbiota -derived Metabolite Analysis | Measurements of short-chain fatty acids in feces during the experiment by using gas chromatography. | Change from baseline outcome measure at 10th week (post-test) | 
| Inflammatory Cytokines TNF-α Analysis | 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). | Change from baseline outcome measure at 10th week (post-test) | 
| Inflammatory Cytokines IL-6 Analysis | 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). | Change from baseline outcome measure at 10th week (post-test) | 
| Inflammatory Cytokines IL-1β Analysis | 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). | Change from baseline outcome measure at 10th week (post-test) | 
| Red blood cells analysis | Use the Clinical Chemistry Analyzer to detection of red blood cells( M/ul) | Change from baseline outcome measure at 10th week (post-test) | 
| Hemoglobin analysis | Use the Clinical Chemistry Analyzer to detection of Hemoglobin(g/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| MCHC(g/dL) analysis | Use the Clinical Chemistry Analyzer to detection of MCHC(g/dL) | Change from baseline outcome measure at 10th week (post-test) | 
| Albumin analysis | Use the Clinical Chemistry Analyzer to detection of albumin(g/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| Hematocrit analysis | Use the Clinical Chemistry Analyzer to detection of Hematocrit(%). | Change from baseline outcome measure at 10th week (post-test) | 
| RDW-CV analysis | Use the Clinical Chemistry Analyzer to detection of RDW-CV(%). | Change from baseline outcome measure at 10th week (post-test) | 
| HbA1C analysis | Use the Clinical Chemistry Analyzer to detection of HbA1C(%). | Change from baseline outcome measure at 10th week (post-test) | 
| MCV analysis | Use the Clinical Chemistry Analyzer to detection of MCV(fL). | Change from baseline outcome measure at 10th week (post-test) | 
| MCH analysis | Use the Clinical Chemistry Analyzer to detection of MCH(pg). | Change from baseline outcome measure at 10th week (post-test) | 
| Platelets analysis | Use the Clinical Chemistry Analyzer to detection of Platelets(k/uL). | Change from baseline outcome measure at 10th week (post-test) | 
| WBC analysis | Use the Clinical Chemistry Analyzer to detection of WBC(k/uL) . | Change from baseline outcome measure at 10th week (post-test) | 
| AST analysis | Use the Clinical Chemistry Analyzer to detection of AST(U/L). | Change from baseline outcome measure at 10th week (post-test) | 
| ALT analysis | Use the Clinical Chemistry Analyzer to detection of ALT(U/L). | Change from baseline outcome measure at 10th week (post-test) | 
| GGT analysis | Use the Clinical Chemistry Analyzer to detection of GGT(U/L). | Change from baseline outcome measure at 10th week (post-test) | 
| T-Cholesterol analysis | Use the Clinical Chemistry Analyzer to detection of T-Cholesterol(mg/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| Triglyceride analysis | Use the Clinical Chemistry Analyzer to detection of triglyceride(mg/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| BUN analysis | Use the Clinical Chemistry Analyzer to detection of BUN(mg/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| Uric acid analysis | Use the Clinical Chemistry Analyzer to detection of Uric acid(mg/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| HDL-C analysis | Use the Clinical Chemistry Analyzer to detection of HDL-C(mg/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| LDL-C analysis | Use the Clinical Chemistry Analyzer to detection of LDL-C(mg/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| hs-CRP analysis | Use the Clinical Chemistry Analyzer to detection of hs-CRP(mg/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| Fasting blood glucose analysis | Use the Clinical Chemistry Analyzer to detection of fasting blood glucose(mg/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| Creatinine analysis | Use the Clinical Chemistry Analyzer to detection of creatinine(mg/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| Free T4 analysis | Use the Clinical Chemistry Analyzer to detection of 【Free T4(ng/dL)】 | Change from baseline outcome measure at 10th week (post-test) | 
| hsTSH analysis | Use the Clinical Chemistry Analyzer to detection of 【hsTSH(ulU/dL)】 | Change from baseline outcome measure at 10th week (post-test) | 
| HOMA-IR analysis | Use the Clinical Chemistry Analyzer to detection of 【 HOMA-IR】 | Change from baseline outcome measure at 10th week (post-test) | 
| Insulin analysis | Use the Clinical Chemistry Analyzer to detection of 【 insulin(uU/dL)】 | Change from baseline outcome measure at 10th week (post-test) | 
| eGFR analysis | Use the Clinical Chemistry Analyzer to detection of 【eGFR (mL/min/1.73^2)】 | Change from baseline outcome measure at 10th week (post-test) | 
| Ca analysis | Use the Clinical Chemistry Analyzer to detection of Ca(mmol/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| specific gravity index analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes specific gravity index (USG). | Change from baseline outcome measure at 10th week (post-test) | 
| Urine pH analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes pH. | Change from baseline outcome measure at 10th week (post-test) | 
| Urine total protein analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Total protein (mg/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| Urine glucose analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes glucose (-/+). | Change from baseline outcome measure at 10th week (post-test) | 
| Urine Urea Nitrogen analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Urine Urea Nitrogen(-/+). | Change from baseline outcome measure at 10th week (post-test) | 
| Urine ketones analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes ketones(-/+). | Change from baseline outcome measure at 10th week (post-test) | 
| Urine Creatinine analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Creatinine(mg/dL). | Change from baseline outcome measure at 10th week (post-test) | 
| Urine bilirubin (dipstick) analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes bilirubin (-/+). | Change from baseline outcome measure at 10th week (post-test) | 
| Urine Albumin analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Albumin(mg/L). | Change from baseline outcome measure at 10th week (post-test) | 
| Urine Albumin/Creatinine analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Albumin/Creatinine(mg/g). | Change from baseline outcome measure at 10th week (post-test) | 
| Urine Nitrite (dipstick) analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Nitrite(-/+). | Change from baseline outcome measure at 10th week (post-test) | 
| Urine WBC esterase analysis | Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes WBC esterase(-/+). | Change from baseline outcome measure at 10th week (post-test) | 
| Superoxide dismutase (SOD) Oxidative stress assessment | Oxidative stress assessment to assess Superoxide dismutase (SOD) in serum was measured by the ELISA kit. | Change from baseline outcome measure at 10th week (post-test) | 
| Glutathione peroxidase (GPx) Oxidative stress assessment | Oxidative stress assessment to assess Glutathione peroxidase (GPx) in serum was measured by the ELISA kit.. | Change from baseline outcome measure at 10th week (post-test) | 
| Catalase Oxidative stress assessment | Oxidative stress assessment to assess Catalase in serum was measured by the ELISA kit.. | Change from baseline outcome measure at 10th week (post-test) | 
| Physical examination-Height | Measure participants' height. The height measurement method is to measure after you take off your shoes and step on the machine. | Change from baseline outcome measure at 10th week (post-test) | 
| Physical examination- Body weight | Measure participants' body weight. The body weight measurement method is to measure after you take off your shoes and step on the weight machine. | Change from baseline outcome measure at 10th week (post-test) | 
| Physical examination - waist circumference | Measure participants' waist circumference. The waist measurement method is to use a tape measure to measure the waist circumference above the human hips. | Change from baseline outcome measure at 10th week (post-test) | 
| Physical examination - arm circumference | 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. . | Change from baseline outcome measure at 10th week (post-test) | 
| Physical examination - calf circumference | 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. | Change from baseline outcome measure at 10th week (post-test) | 
| Physical examination - hip circumference | Measure participants' hip circumference. The hip measurement method is to use a tape measure to measure the maximum hip diameter. | Change from baseline outcome measure at 10th week (post-test) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Questionnaire assessment | Using Physical Activity Questionnaire to assess participants' activity level. | Change from baseline outcome measure at 10th week (post-test) | 
| 24-hour Dietary Recall Form | 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. | Change from baseline outcome measure at 10th week (post-test) | 
| Gastrointestinal Function Assessment | Assess the number of bowel movements, bowel habits, bowel pattern, and flatulence | Change from baseline outcome measure at 10th week (post-test) | 
| Mini nutrition assessment | 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. | Change from baseline outcome measure at 10th week (post-test) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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protein