SarcopeniaKPSNCT04951843
Koji Product Supplementation' s Study
A study testing Black soybean koji product in people with Sarcopenia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Black soybean koji product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Oct 2018to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Black Soybeans Koji Product Supplementation on Nutrients Absorption and Anti-aging Effect in Elderly
The present project is to identify the effect of black soy beans Koji product supplementation on nutrients absorption and anti-aging effect in elderly.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- Black soybean koji product
- Keywords
- protein
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black soybean koji productDietary supplement
Black soybean koji product
| Study group | Role | What they receive |
|---|---|---|
| Black soybean koji product | Experimental | Oral supplement 2 servings of black soybean koji product per day, for 10 weeks. Receives: Dietary Supplement: Black soybean koji product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
.
Measured: 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.
.
Measured: 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).
Measured: 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.
.
Measured: Change from baseline outcome measure at 10th week (post-test)
Muscle Strength - Hand Grip Strength
Using hand grips to measure hand grip strength.
Measured: Change from baseline outcome measure at 10th week (post-test)
Physical Performance - Walking Speed
Measuring participants' speed to walk 5 ft.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: Change from baseline outcome measure at 10th week (post-test)
Hemoglobin analysis
Use the Clinical Chemistry Analyzer to detection of Hemoglobin(g/dL).
Measured: 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)
Measured: Change from baseline outcome measure at 10th week (post-test)
Albumin analysis
Use the Clinical Chemistry Analyzer to detection of albumin(g/dL).
Measured: Change from baseline outcome measure at 10th week (post-test)
Hematocrit analysis
Use the Clinical Chemistry Analyzer to detection of Hematocrit(%).
Measured: Change from baseline outcome measure at 10th week (post-test)
RDW-CV analysis
Use the Clinical Chemistry Analyzer to detection of RDW-CV(%).
Measured: Change from baseline outcome measure at 10th week (post-test)
HbA1C analysis
Use the Clinical Chemistry Analyzer to detection of HbA1C(%).
Measured: Change from baseline outcome measure at 10th week (post-test)
MCV analysis
Use the Clinical Chemistry Analyzer to detection of MCV(fL).
Measured: Change from baseline outcome measure at 10th week (post-test)
MCH analysis
Use the Clinical Chemistry Analyzer to detection of MCH(pg).
Measured: Change from baseline outcome measure at 10th week (post-test)
Platelets analysis
Use the Clinical Chemistry Analyzer to detection of Platelets(k/uL).
Measured: Change from baseline outcome measure at 10th week (post-test)
WBC analysis
Use the Clinical Chemistry Analyzer to detection of WBC(k/uL) .
Measured: Change from baseline outcome measure at 10th week (post-test)
AST analysis
Use the Clinical Chemistry Analyzer to detection of AST(U/L).
Measured: Change from baseline outcome measure at 10th week (post-test)
ALT analysis
Use the Clinical Chemistry Analyzer to detection of ALT(U/L).
Measured: Change from baseline outcome measure at 10th week (post-test)
GGT analysis
Use the Clinical Chemistry Analyzer to detection of GGT(U/L).
Measured: 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).
Measured: Change from baseline outcome measure at 10th week (post-test)
Triglyceride analysis
Use the Clinical Chemistry Analyzer to detection of triglyceride(mg/dL).
Measured: Change from baseline outcome measure at 10th week (post-test)
BUN analysis
Use the Clinical Chemistry Analyzer to detection of BUN(mg/dL).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Change from baseline outcome measure at 10th week (post-test)
Creatinine analysis
Use the Clinical Chemistry Analyzer to detection of creatinine(mg/dL).
Measured: 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)】
Measured: Change from baseline outcome measure at 10th week (post-test)
hsTSH analysis
Use the Clinical Chemistry Analyzer to detection of 【hsTSH(ulU/dL)】
Measured: Change from baseline outcome measure at 10th week (post-test)
HOMA-IR analysis
Use the Clinical Chemistry Analyzer to detection of 【 HOMA-IR】
Measured: Change from baseline outcome measure at 10th week (post-test)
Insulin analysis
Use the Clinical Chemistry Analyzer to detection of 【 insulin(uU/dL)】
Measured: 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)】
Measured: Change from baseline outcome measure at 10th week (post-test)
Ca analysis
Use the Clinical Chemistry Analyzer to detection of Ca(mmol/dL).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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 (-/+).
Measured: 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(-/+).
Measured: 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(-/+).
Measured: 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).
Measured: 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 (-/+).
Measured: 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).
Measured: 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).
Measured: 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(-/+).
Measured: 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(-/+).
Measured: 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.
Measured: 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..
Measured: 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..
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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. .
Measured: 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.
Measured: 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.
Measured: Change from baseline outcome measure at 10th week (post-test)
Secondary outcomes (4)
Physical Activity Questionnaire assessment
Using Physical Activity Questionnaire to assess participants' activity level.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Change from baseline outcome measure at 10th week (post-test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start12 Oct 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, Taipei Medical University
- Responsible party
- Sponsor
- Investigators
- Hui-Yu Huang, Ph.D, Study chair, Taipei Medical University Graduate Institute of Metabolism and Obesity Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951843
- Sponsor's protocol ID
- 201806058RINA
- Acronym
- KPS
- Status last verified
- Jun 2021
- First submitted
- 15 Apr 2019
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Black Soybeans Koji Product Supplementation on Nutrients Absorption and Anti-aging Effect in Elderly
- ClinicalTrials.gov ID
- NCT04951843
- Acronym / sponsor ID
- KPS / 201806058RINA
- Conditions
- Sarcopenia
- Keywords
- protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan, Taipei Medical University
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Black soybean koji product | Experimental | Dietary Supplement: Black soybean koji productOral supplement 2 servings of black soybean koji product per day, for 10 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 1-2 items are necessary, 3-5 can match one item
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black soybean koji productBlack soybean koji product | Dietary supplement | Black soybean koji product |
Primary outcome
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.
4 secondary outcomes
Physical Activity Questionnaire assessment
Time frame: Change from baseline outcome measure at 10th week (post-test)
24-hour Dietary Recall Form
Time frame: Change from baseline outcome measure at 10th week (post-test)
Gastrointestinal Function Assessment
Time frame: Change from baseline outcome measure at 10th week (post-test)
Mini nutrition assessment
Time frame: Change from baseline outcome measure at 10th week (post-test)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Yu Huang, Ph.D study chair
Taipei Medical University Graduate Institute of Metabolism and Obesity Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black soybean koji product in people with Sarcopenia, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: Change from baseline outcome measure at 10th week (post-test)). The study lists 65 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.