The Effect of Black Soybeans Koji Product Supplementation on Nutrients Absorption and Anti-aging Effect in Elderly
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Urine bilirubin (dipstick) analysis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Black soybean koji product
Oral supplement 2 servings of black soybean koji product per day, for 10 weeks.
Intervention: Black soybean koji product (Dietary Supplement)
Outcomes
Primary Outcomes
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 (-/+).
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).
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).
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.
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 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).
HbA1C analysis
Time Frame: Change from baseline outcome measure at 10th week (post-test)
Use the Clinical Chemistry Analyzer to detection of HbA1C(%).
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).
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 - 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.
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.
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)
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)
Hematocrit analysis
Time Frame: Change from baseline outcome measure at 10th week (post-test)
Use the Clinical Chemistry Analyzer to detection of Hematocrit(%).
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).
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).
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) .
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).
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).
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).
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).
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.
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. .
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. .
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(%).
MCH analysis
Time Frame: Change from baseline outcome measure at 10th week (post-test)
Use the Clinical Chemistry Analyzer to detection of MCH(pg).
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).
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).
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).
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).
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).
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.
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).
MCV analysis
Time Frame: Change from baseline outcome measure at 10th week (post-test)
Use the Clinical Chemistry Analyzer to detection of MCV(fL).
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) .
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).
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)】
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(-/+).
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. .
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).
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).
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)】
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】
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 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 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 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..
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).
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)】
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)】
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(-/+).
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 - 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 Outcomes
- Physical Activity Questionnaire assessment(Change from baseline outcome measure at 10th week (post-test))
- 24-hour Dietary Recall Form(Change from baseline outcome measure at 10th week (post-test))
- Gastrointestinal Function Assessment(Change from baseline outcome measure at 10th week (post-test))
- Mini nutrition assessment(Change from baseline outcome measure at 10th week (post-test))
