The present project is to identify the effect of black soy beans Koji product supplementation on nutrients absorption and anti-aging effect in elderly.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
60
Black soybean koji product
Taipei Medical University
Taipei, Taiwan
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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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) .
Time frame: 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. .
Time frame: Change from baseline outcome measure at 10th week (post-test)
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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).
Time frame: 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. .
Time frame: Change from baseline outcome measure at 10th week (post-test)
Muscle Strength - Hand Grip Strength
Using hand grips to measure hand grip strength.
Time frame: Change from baseline outcome measure at 10th week (post-test)
Physical Performance - Walking Speed
Measuring participants' speed to walk 5 ft.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: Change from baseline outcome measure at 10th week (post-test)
Hemoglobin analysis
Use the Clinical Chemistry Analyzer to detection of Hemoglobin(g/dL).
Time frame: 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)
Time frame: Change from baseline outcome measure at 10th week (post-test)
Albumin analysis
Use the Clinical Chemistry Analyzer to detection of albumin(g/dL).
Time frame: Change from baseline outcome measure at 10th week (post-test)
Hematocrit analysis
Use the Clinical Chemistry Analyzer to detection of Hematocrit(%).
Time frame: Change from baseline outcome measure at 10th week (post-test)
RDW-CV analysis
Use the Clinical Chemistry Analyzer to detection of RDW-CV(%).
Time frame: Change from baseline outcome measure at 10th week (post-test)
HbA1C analysis
Use the Clinical Chemistry Analyzer to detection of HbA1C(%).
Time frame: Change from baseline outcome measure at 10th week (post-test)
MCV analysis
Use the Clinical Chemistry Analyzer to detection of MCV(fL).
Time frame: Change from baseline outcome measure at 10th week (post-test)
MCH analysis
Use the Clinical Chemistry Analyzer to detection of MCH(pg).
Time frame: Change from baseline outcome measure at 10th week (post-test)
Platelets analysis
Use the Clinical Chemistry Analyzer to detection of Platelets(k/uL).
Time frame: Change from baseline outcome measure at 10th week (post-test)
WBC analysis
Use the Clinical Chemistry Analyzer to detection of WBC(k/uL) .
Time frame: Change from baseline outcome measure at 10th week (post-test)
AST analysis
Use the Clinical Chemistry Analyzer to detection of AST(U/L).
Time frame: Change from baseline outcome measure at 10th week (post-test)
ALT analysis
Use the Clinical Chemistry Analyzer to detection of ALT(U/L).
Time frame: Change from baseline outcome measure at 10th week (post-test)
GGT analysis
Use the Clinical Chemistry Analyzer to detection of GGT(U/L).
Time frame: 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).
Time frame: Change from baseline outcome measure at 10th week (post-test)
Triglyceride analysis
Use the Clinical Chemistry Analyzer to detection of triglyceride(mg/dL).
Time frame: Change from baseline outcome measure at 10th week (post-test)
BUN analysis
Use the Clinical Chemistry Analyzer to detection of BUN(mg/dL).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Change from baseline outcome measure at 10th week (post-test)
Creatinine analysis
Use the Clinical Chemistry Analyzer to detection of creatinine(mg/dL).
Time frame: 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)】
Time frame: Change from baseline outcome measure at 10th week (post-test)
hsTSH analysis
Use the Clinical Chemistry Analyzer to detection of 【hsTSH(ulU/dL)】
Time frame: Change from baseline outcome measure at 10th week (post-test)
HOMA-IR analysis
Use the Clinical Chemistry Analyzer to detection of 【 HOMA-IR】
Time frame: Change from baseline outcome measure at 10th week (post-test)
Insulin analysis
Use the Clinical Chemistry Analyzer to detection of 【 insulin(uU/dL)】
Time frame: 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)】
Time frame: Change from baseline outcome measure at 10th week (post-test)
Ca analysis
Use the Clinical Chemistry Analyzer to detection of Ca(mmol/dL).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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 (-/+).
Time frame: 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(-/+).
Time frame: 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(-/+).
Time frame: 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).
Time frame: 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 (-/+).
Time frame: 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).
Time frame: 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).
Time frame: 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(-/+).
Time frame: 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(-/+).
Time frame: 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.
Time frame: 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..
Time frame: 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..
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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. .
Time frame: 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.
Time frame: 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.
Time frame: Change from baseline outcome measure at 10th week (post-test)
Physical Activity Questionnaire assessment
Using Physical Activity Questionnaire to assess participants' activity level.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Change from baseline outcome measure at 10th week (post-test)