Back to resultsKoji Product Supplementation' s Study (KPS)
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Black soybean koji product
Sponsored by
About this trial
This is an interventional prevention trial for Sarcopenia focused on measuring protein
Eligibility Criteria
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.
Sites / Locations
- Taipei Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Black soybean koji product
Arm Description
Oral supplement 2 servings of black soybean koji product per day, for 10 weeks.
Outcomes
Primary Outcome Measures
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).
Fat mass
Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure fat mass.
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.
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).
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)
.
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.
.
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).
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.
.
Muscle Strength - Hand Grip Strength
Using hand grips to measure hand grip strength.
Physical Performance - Walking Speed
Measuring participants' speed to walk 5 ft.
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).
Gut Microbiota -derived Metabolite Analysis
Measurements of short-chain fatty acids in feces during the experiment by using gas chromatography.
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).
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).
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).
Red blood cells analysis
Use the Clinical Chemistry Analyzer to detection of red blood cells( M/ul)
Hemoglobin analysis
Use the Clinical Chemistry Analyzer to detection of Hemoglobin(g/dL).
MCHC(g/dL) analysis
Use the Clinical Chemistry Analyzer to detection of MCHC(g/dL)
Albumin analysis
Use the Clinical Chemistry Analyzer to detection of albumin(g/dL).
Hematocrit analysis
Use the Clinical Chemistry Analyzer to detection of Hematocrit(%).
RDW-CV analysis
Use the Clinical Chemistry Analyzer to detection of RDW-CV(%).
HbA1C analysis
Use the Clinical Chemistry Analyzer to detection of HbA1C(%).
MCV analysis
Use the Clinical Chemistry Analyzer to detection of MCV(fL).
MCH analysis
Use the Clinical Chemistry Analyzer to detection of MCH(pg).
Platelets analysis
Use the Clinical Chemistry Analyzer to detection of Platelets(k/uL).
WBC analysis
Use the Clinical Chemistry Analyzer to detection of WBC(k/uL) .
AST analysis
Use the Clinical Chemistry Analyzer to detection of AST(U/L).
ALT analysis
Use the Clinical Chemistry Analyzer to detection of ALT(U/L).
GGT analysis
Use the Clinical Chemistry Analyzer to detection of GGT(U/L).
T-Cholesterol analysis
Use the Clinical Chemistry Analyzer to detection of T-Cholesterol(mg/dL).
Triglyceride analysis
Use the Clinical Chemistry Analyzer to detection of triglyceride(mg/dL).
BUN analysis
Use the Clinical Chemistry Analyzer to detection of BUN(mg/dL).
Uric acid analysis
Use the Clinical Chemistry Analyzer to detection of Uric acid(mg/dL).
HDL-C analysis
Use the Clinical Chemistry Analyzer to detection of HDL-C(mg/dL).
LDL-C analysis
Use the Clinical Chemistry Analyzer to detection of LDL-C(mg/dL).
hs-CRP analysis
Use the Clinical Chemistry Analyzer to detection of hs-CRP(mg/dL).
Fasting blood glucose analysis
Use the Clinical Chemistry Analyzer to detection of fasting blood glucose(mg/dL).
Creatinine analysis
Use the Clinical Chemistry Analyzer to detection of creatinine(mg/dL).
Free T4 analysis
Use the Clinical Chemistry Analyzer to detection of 【Free T4(ng/dL)】
hsTSH analysis
Use the Clinical Chemistry Analyzer to detection of 【hsTSH(ulU/dL)】
HOMA-IR analysis
Use the Clinical Chemistry Analyzer to detection of 【 HOMA-IR】
Insulin analysis
Use the Clinical Chemistry Analyzer to detection of 【 insulin(uU/dL)】
eGFR analysis
Use the Clinical Chemistry Analyzer to detection of 【eGFR (mL/min/1.73^2)】
Ca analysis
Use the Clinical Chemistry Analyzer to detection of Ca(mmol/dL).
specific gravity index analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes specific gravity index (USG).
Urine pH analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes pH.
Urine total protein analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Total protein (mg/dL).
Urine glucose analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes glucose (-/+).
Urine Urea Nitrogen analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Urine Urea Nitrogen(-/+).
Urine ketones analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes ketones(-/+).
Urine Creatinine analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Creatinine(mg/dL).
Urine bilirubin (dipstick) analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes bilirubin (-/+).
Urine Albumin analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Albumin(mg/L).
Urine Albumin/Creatinine analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Albumin/Creatinine(mg/g).
Urine Nitrite (dipstick) analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Nitrite(-/+).
Urine WBC esterase analysis
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes WBC esterase(-/+).
Superoxide dismutase (SOD) Oxidative stress assessment
Oxidative stress assessment to assess Superoxide dismutase (SOD) in serum was measured by the ELISA kit.
Glutathione peroxidase (GPx) Oxidative stress assessment
Oxidative stress assessment to assess Glutathione peroxidase (GPx) in serum was measured by the ELISA kit..
Catalase Oxidative stress assessment
Oxidative stress assessment to assess Catalase in serum was measured by the ELISA kit..
Physical examination-Height
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
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
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
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
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
Measure participants' hip circumference. The hip measurement method is to use a tape measure to measure the maximum hip diameter.
Secondary Outcome Measures
Physical Activity Questionnaire assessment
Using Physical Activity Questionnaire to assess participants' activity level.
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.
Gastrointestinal Function Assessment
Assess the number of bowel movements, bowel habits, bowel pattern, and flatulence
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.
Full Information
NCT ID
NCT04951843
First Posted
April 15, 2019
Last Updated
June 27, 2021
Sponsor
National Taiwan University Hospital
Collaborators
Ministry of Science and Technology, Taiwan, Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04951843
Brief Title
Koji Product Supplementation' s Study
Acronym
KPS
Official Title
The Effect of Black Soybeans Koji Product Supplementation on Nutrients Absorption and Anti-aging Effect in Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
Ministry of Science and Technology, Taiwan, Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
protein
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Black soybean koji product
Arm Type
Experimental
Arm Description
Oral supplement 2 servings of black soybean koji product per day, for 10 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Black soybean koji product
Intervention Description
Black soybean koji product
Primary Outcome Measure Information:
Title
Body mass index
Description
Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure body mass index (BMI).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Fat mass
Description
Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure fat mass.
Time Frame
Change from baseline outcome measure at 10th week (post-test).
Title
Muscle mas
Description
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.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Visceral fat area(VFA)
Description
Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Visceral fat area(VFA) (cm2).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
BIA - Basal Metabolic Rate(BMR)
Description
Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Basal Metabolic Rate(BMR) (kcal)
.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
whole body Mineral
Description
Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Mineral (kg) in whole body.
.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Bone Mineral Content
Description
Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Bone Mineral Content (kg).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Cellular Water
Description
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.
.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Muscle Strength - Hand Grip Strength
Description
Using hand grips to measure hand grip strength.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Physical Performance - Walking Speed
Description
Measuring participants' speed to walk 5 ft.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Gut Microbiota Composition Analysis
Description
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).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Gut Microbiota -derived Metabolite Analysis
Description
Measurements of short-chain fatty acids in feces during the experiment by using gas chromatography.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Inflammatory Cytokines TNF-α Analysis
Description
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).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Inflammatory Cytokines IL-6 Analysis
Description
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).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Inflammatory Cytokines IL-1β Analysis
Description
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).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Red blood cells analysis
Description
Use the Clinical Chemistry Analyzer to detection of red blood cells( M/ul)
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Hemoglobin analysis
Description
Use the Clinical Chemistry Analyzer to detection of Hemoglobin(g/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
MCHC(g/dL) analysis
Description
Use the Clinical Chemistry Analyzer to detection of MCHC(g/dL)
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Albumin analysis
Description
Use the Clinical Chemistry Analyzer to detection of albumin(g/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Hematocrit analysis
Description
Use the Clinical Chemistry Analyzer to detection of Hematocrit(%).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
RDW-CV analysis
Description
Use the Clinical Chemistry Analyzer to detection of RDW-CV(%).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
HbA1C analysis
Description
Use the Clinical Chemistry Analyzer to detection of HbA1C(%).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
MCV analysis
Description
Use the Clinical Chemistry Analyzer to detection of MCV(fL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
MCH analysis
Description
Use the Clinical Chemistry Analyzer to detection of MCH(pg).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Platelets analysis
Description
Use the Clinical Chemistry Analyzer to detection of Platelets(k/uL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
WBC analysis
Description
Use the Clinical Chemistry Analyzer to detection of WBC(k/uL) .
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
AST analysis
Description
Use the Clinical Chemistry Analyzer to detection of AST(U/L).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
ALT analysis
Description
Use the Clinical Chemistry Analyzer to detection of ALT(U/L).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
GGT analysis
Description
Use the Clinical Chemistry Analyzer to detection of GGT(U/L).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
T-Cholesterol analysis
Description
Use the Clinical Chemistry Analyzer to detection of T-Cholesterol(mg/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Triglyceride analysis
Description
Use the Clinical Chemistry Analyzer to detection of triglyceride(mg/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
BUN analysis
Description
Use the Clinical Chemistry Analyzer to detection of BUN(mg/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Uric acid analysis
Description
Use the Clinical Chemistry Analyzer to detection of Uric acid(mg/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
HDL-C analysis
Description
Use the Clinical Chemistry Analyzer to detection of HDL-C(mg/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
LDL-C analysis
Description
Use the Clinical Chemistry Analyzer to detection of LDL-C(mg/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
hs-CRP analysis
Description
Use the Clinical Chemistry Analyzer to detection of hs-CRP(mg/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Fasting blood glucose analysis
Description
Use the Clinical Chemistry Analyzer to detection of fasting blood glucose(mg/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Creatinine analysis
Description
Use the Clinical Chemistry Analyzer to detection of creatinine(mg/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Free T4 analysis
Description
Use the Clinical Chemistry Analyzer to detection of 【Free T4(ng/dL)】
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
hsTSH analysis
Description
Use the Clinical Chemistry Analyzer to detection of 【hsTSH(ulU/dL)】
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
HOMA-IR analysis
Description
Use the Clinical Chemistry Analyzer to detection of 【 HOMA-IR】
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Insulin analysis
Description
Use the Clinical Chemistry Analyzer to detection of 【 insulin(uU/dL)】
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
eGFR analysis
Description
Use the Clinical Chemistry Analyzer to detection of 【eGFR (mL/min/1.73^2)】
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Ca analysis
Description
Use the Clinical Chemistry Analyzer to detection of Ca(mmol/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
specific gravity index analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes specific gravity index (USG).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Urine pH analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes pH.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Urine total protein analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Total protein (mg/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Urine glucose analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes glucose (-/+).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Urine Urea Nitrogen analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Urine Urea Nitrogen(-/+).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Urine ketones analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes ketones(-/+).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Urine Creatinine analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Creatinine(mg/dL).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Urine bilirubin (dipstick) analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes bilirubin (-/+).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Urine Albumin analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Albumin(mg/L).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Urine Albumin/Creatinine analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Albumin/Creatinine(mg/g).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Urine Nitrite (dipstick) analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Nitrite(-/+).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Urine WBC esterase analysis
Description
Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes WBC esterase(-/+).
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Superoxide dismutase (SOD) Oxidative stress assessment
Description
Oxidative stress assessment to assess Superoxide dismutase (SOD) in serum was measured by the ELISA kit.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Glutathione peroxidase (GPx) Oxidative stress assessment
Description
Oxidative stress assessment to assess Glutathione peroxidase (GPx) in serum was measured by the ELISA kit..
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Catalase Oxidative stress assessment
Description
Oxidative stress assessment to assess Catalase in serum was measured by the ELISA kit..
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Physical examination-Height
Description
Measure participants' height. The height measurement method is to measure after you take off your shoes and step on the machine.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Physical examination- Body weight
Description
Measure participants' body weight. The body weight measurement method is to measure after you take off your shoes and step on the weight machine.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Physical examination - waist circumference
Description
Measure participants' waist circumference. The waist measurement method is to use a tape measure to measure the waist circumference above the human hips.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Physical examination - arm circumference
Description
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. .
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Physical examination - calf circumference
Description
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.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Physical examination - hip circumference
Description
Measure participants' hip circumference. The hip measurement method is to use a tape measure to measure the maximum hip diameter.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Secondary Outcome Measure Information:
Title
Physical Activity Questionnaire assessment
Description
Using Physical Activity Questionnaire to assess participants' activity level.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
24-hour Dietary Recall Form
Description
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.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Gastrointestinal Function Assessment
Description
Assess the number of bowel movements, bowel habits, bowel pattern, and flatulence
Time Frame
Change from baseline outcome measure at 10th week (post-test)
Title
Mini nutrition assessment
Description
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.
Time Frame
Change from baseline outcome measure at 10th week (post-test)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Yu Huang, Ph.D
Organizational Affiliation
Taipei Medical University Graduate Institute of Metabolism and Obesity Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Medical University
City
Taipei City
ZIP/Postal Code
110
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Koji Product Supplementation' s Study
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