Koji Product Supplementation' s Study

Sarcopenia Clinical Trial

— KPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04951843
• Other study ID #: 201806058RINA
• Status: Completed
• Phase: N/A
• Start date: October 12, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: June 2021
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 1-2 items are necessary, 3-5 can match one item

1. Age above 65 years

2. Oral intake

3. Walking speed: = 0.8 m/s (measured by time for a 5-meter usual gait)

4. Handgrip strength: Men: <26 kg Women: <18 kg (measured by electronic hand grip dynamometer)

5. Calf circumference: Men: = 34 cm Women: = 33 cm

Exclusion Criteria:

1. Participant in a moderate or strenuous exercise

2. Unable to walk

3. Unable to take in food from the mouth

4. People who can't record or communicate.

5. Refuse to accept the 3-day diet record

6. Allergic to black soybeans or legumes

7. Allergic to egg or milk

8. Infected with disease and had to be hospitalized for treatment before 4 weeks of the intervention test start

9. A patient who has been diagnosed with a malignant tumor or has a history of malignancy in the past year.

10. The estimated glomerular filtration rate (eGFR) is less than 60 ml/min/1.73 m2 in the past three months.

11. Hypothyroidism

12. People who often have symptoms of gastrointestinal upset.

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Dietary Supplement:
• Black soybean koji product
Black soybean koji product

Locations

Country	Name	City	State
Taiwan	Taipei Medical University	Taipei City

Sponsors (3)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Ministry of Science and Technology, Taiwan, Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body mass index	Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure body mass index (BMI).	Change from baseline outcome measure at 10th week (post-test)
Primary	Fat mass	Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure fat mass.	Change from baseline outcome measure at 10th week (post-test).
Primary	Muscle mas	Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure whole body and appendicular skeletal muscle mass.	Change from baseline outcome measure at 10th week (post-test)
Primary	Visceral fat area(VFA)	Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Visceral fat area(VFA) (cm2).	Change from baseline outcome measure at 10th week (post-test)
Primary	BIA - Basal Metabolic Rate(BMR)	Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Basal Metabolic Rate(BMR) (kcal); .	Change from baseline outcome measure at 10th week (post-test)
Primary	whole body Mineral	Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Mineral (kg) in whole body.; .	Change from baseline outcome measure at 10th week (post-test)
Primary	Bone Mineral Content	Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure Bone Mineral Content (kg).	Change from baseline outcome measure at 10th week (post-test)
Primary	Cellular Water	Measure Participants' detected body composition by using bioelectrical impedance analysis (BIA) as a non-invasive test instrument to measure whole body Extracellular Water (L), Intracellular Water(L), and Total Body Water (L), et al.; .	Change from baseline outcome measure at 10th week (post-test)
Primary	Muscle Strength - Hand Grip Strength	Using hand grips to measure hand grip strength.	Change from baseline outcome measure at 10th week (post-test)
Primary	Physical Performance - Walking Speed	Measuring participants' speed to walk 5 ft.	Change from baseline outcome measure at 10th week (post-test)
Primary	Gut Microbiota Composition Analysis	Total genome DNA from samples was extracted from stool samples using the CTAB/SDS method. One hundred ng of DNA was amplified with barcoded primers16S V3+V4: 314F-806R annealing to the V3-V4region of the 16S rRNA. All of the PCR reactions were carried out using a Phusion® High-Fidelity PCR Master Mix (New England Biolabs, Location). Samples with a bright main strip between 400 and 450bp were selected from 2% agarose gel for further experiments. Mixture PCR products were purified using a Qiagen Gel Extraction Kit (Qiagen, Germany). Libraries were generated with the TruSeq® DNA PCR-Free Sample Preparation Kit and quantified with Qubit and Q-PCR. The purified DNA was then sequenced using the HiSeq2500 PE250 (Company, Location).	Change from baseline outcome measure at 10th week (post-test)
Primary	Gut Microbiota -derived Metabolite Analysis	Measurements of short-chain fatty acids in feces during the experiment by using gas chromatography.	Change from baseline outcome measure at 10th week (post-test)
Primary	Inflammatory Cytokines TNF-a Analysis	The inflammation-associated serum cytokines TNF-a was analyzed using colorimetric kits (Company, Location). Thioredoxin (Cloud-Clone Corp, SEA702Hu, City, State, USA) and Complement Component 5a (Cloud-Clone Corp, SEA388Hu) in the urine was evaluated for the effects of inflammation states and also assessed using colorimetric kits. The procedures followed the kit instructions and were measured using an ELISA reader (Bio Tek, PowerWave XS2, City, State, USA).	Change from baseline outcome measure at 10th week (post-test)
Primary	Inflammatory Cytokines IL-6 Analysis	The inflammation-associated serum cytokines IL-6 was analyzed using colorimetric kits (Company, Location). Thioredoxin (Cloud-Clone Corp, SEA702Hu, City, State, USA) and Complement Component 5a (Cloud-Clone Corp, SEA388Hu) in the urine was evaluated for the effects of inflammation states and also assessed using colorimetric kits. The procedures followed the kit instructions and were measured using an ELISA reader (Bio Tek, PowerWave XS2, City, State, USA).	Change from baseline outcome measure at 10th week (post-test)
Primary	Inflammatory Cytokines IL-1ß Analysis	The inflammation-associated serum cytokines IL-1ß (BioLegend, City, State, USA) was analyzed using colorimetric kits (Company, Location). Thioredoxin (Cloud-Clone Corp, SEA702Hu, City, State, USA) and Complement Component 5a (Cloud-Clone Corp, SEA388Hu) in the urine was evaluated for the effects of inflammation states and also assessed using colorimetric kits. The procedures followed the kit instructions and were measured using an ELISA reader (Bio Tek, PowerWave XS2, City, State, USA).	Change from baseline outcome measure at 10th week (post-test)
Primary	Red blood cells analysis	Use the Clinical Chemistry Analyzer to detection of red blood cells( M/ul)	Change from baseline outcome measure at 10th week (post-test)
Primary	Hemoglobin analysis	Use the Clinical Chemistry Analyzer to detection of Hemoglobin(g/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	MCHC(g/dL) analysis	Use the Clinical Chemistry Analyzer to detection of MCHC(g/dL)	Change from baseline outcome measure at 10th week (post-test)
Primary	Albumin analysis	Use the Clinical Chemistry Analyzer to detection of albumin(g/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	Hematocrit analysis	Use the Clinical Chemistry Analyzer to detection of Hematocrit(%).	Change from baseline outcome measure at 10th week (post-test)
Primary	RDW-CV analysis	Use the Clinical Chemistry Analyzer to detection of RDW-CV(%).	Change from baseline outcome measure at 10th week (post-test)
Primary	HbA1C analysis	Use the Clinical Chemistry Analyzer to detection of HbA1C(%).	Change from baseline outcome measure at 10th week (post-test)
Primary	MCV analysis	Use the Clinical Chemistry Analyzer to detection of MCV(fL).	Change from baseline outcome measure at 10th week (post-test)
Primary	MCH analysis	Use the Clinical Chemistry Analyzer to detection of MCH(pg).	Change from baseline outcome measure at 10th week (post-test)
Primary	Platelets analysis	Use the Clinical Chemistry Analyzer to detection of Platelets(k/uL).	Change from baseline outcome measure at 10th week (post-test)
Primary	WBC analysis	Use the Clinical Chemistry Analyzer to detection of WBC(k/uL) .	Change from baseline outcome measure at 10th week (post-test)
Primary	AST analysis	Use the Clinical Chemistry Analyzer to detection of AST(U/L).	Change from baseline outcome measure at 10th week (post-test)
Primary	ALT analysis	Use the Clinical Chemistry Analyzer to detection of ALT(U/L).	Change from baseline outcome measure at 10th week (post-test)
Primary	GGT analysis	Use the Clinical Chemistry Analyzer to detection of GGT(U/L).	Change from baseline outcome measure at 10th week (post-test)
Primary	T-Cholesterol analysis	Use the Clinical Chemistry Analyzer to detection of T-Cholesterol(mg/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	Triglyceride analysis	Use the Clinical Chemistry Analyzer to detection of triglyceride(mg/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	BUN analysis	Use the Clinical Chemistry Analyzer to detection of BUN(mg/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	Uric acid analysis	Use the Clinical Chemistry Analyzer to detection of Uric acid(mg/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	HDL-C analysis	Use the Clinical Chemistry Analyzer to detection of HDL-C(mg/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	LDL-C analysis	Use the Clinical Chemistry Analyzer to detection of LDL-C(mg/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	hs-CRP analysis	Use the Clinical Chemistry Analyzer to detection of hs-CRP(mg/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	Fasting blood glucose analysis	Use the Clinical Chemistry Analyzer to detection of fasting blood glucose(mg/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	Creatinine analysis	Use the Clinical Chemistry Analyzer to detection of creatinine(mg/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	Free T4 analysis	Use the Clinical Chemistry Analyzer to detection of ?Free T4(ng/dL)?	Change from baseline outcome measure at 10th week (post-test)
Primary	hsTSH analysis	Use the Clinical Chemistry Analyzer to detection of ?hsTSH(ulU/dL)?	Change from baseline outcome measure at 10th week (post-test)
Primary	HOMA-IR analysis	Use the Clinical Chemistry Analyzer to detection of ? HOMA-IR?	Change from baseline outcome measure at 10th week (post-test)
Primary	Insulin analysis	Use the Clinical Chemistry Analyzer to detection of ? insulin(uU/dL)?	Change from baseline outcome measure at 10th week (post-test)
Primary	eGFR analysis	Use the Clinical Chemistry Analyzer to detection of ?eGFR (mL/min/1.73^2)?	Change from baseline outcome measure at 10th week (post-test)
Primary	Ca analysis	Use the Clinical Chemistry Analyzer to detection of Ca(mmol/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	specific gravity index analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes specific gravity index (USG).	Change from baseline outcome measure at 10th week (post-test)
Primary	Urine pH analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes pH.	Change from baseline outcome measure at 10th week (post-test)
Primary	Urine total protein analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Total protein (mg/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	Urine glucose analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes glucose (-/+).	Change from baseline outcome measure at 10th week (post-test)
Primary	Urine Urea Nitrogen analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Urine Urea Nitrogen(-/+).	Change from baseline outcome measure at 10th week (post-test)
Primary	Urine ketones analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes ketones(-/+).	Change from baseline outcome measure at 10th week (post-test)
Primary	Urine Creatinine analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Creatinine(mg/dL).	Change from baseline outcome measure at 10th week (post-test)
Primary	Urine bilirubin (dipstick) analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes bilirubin (-/+).	Change from baseline outcome measure at 10th week (post-test)
Primary	Urine Albumin analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Albumin(mg/L).	Change from baseline outcome measure at 10th week (post-test)
Primary	Urine Albumin/Creatinine analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Albumin/Creatinine(mg/g).	Change from baseline outcome measure at 10th week (post-test)
Primary	Urine Nitrite (dipstick) analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes Nitrite(-/+).	Change from baseline outcome measure at 10th week (post-test)
Primary	Urine WBC esterase analysis	Fasting for 8 hours, collecting 10ml urine. Routine urine analysis which includes WBC esterase(-/+).	Change from baseline outcome measure at 10th week (post-test)
Primary	Superoxide dismutase (SOD) Oxidative stress assessment	Oxidative stress assessment to assess Superoxide dismutase (SOD) in serum was measured by the ELISA kit.	Change from baseline outcome measure at 10th week (post-test)
Primary	Glutathione peroxidase (GPx) Oxidative stress assessment	Oxidative stress assessment to assess Glutathione peroxidase (GPx) in serum was measured by the ELISA kit..	Change from baseline outcome measure at 10th week (post-test)
Primary	Catalase Oxidative stress assessment	Oxidative stress assessment to assess Catalase in serum was measured by the ELISA kit..	Change from baseline outcome measure at 10th week (post-test)
Primary	Physical examination-Height	Measure participants' height. The height measurement method is to measure after you take off your shoes and step on the machine.	Change from baseline outcome measure at 10th week (post-test)
Primary	Physical examination- Body weight	Measure participants' body weight. The body weight measurement method is to measure after you take off your shoes and step on the weight machine.	Change from baseline outcome measure at 10th week (post-test)
Primary	Physical examination - waist circumference	Measure participants' waist circumference. The waist measurement method is to use a tape measure to measure the waist circumference above the human hips.	Change from baseline outcome measure at 10th week (post-test)
Primary	Physical examination - arm circumference	Measure participants' arm circumference. The measurement method of the arm circumference is the circumference of the upper arm and is measured at the mid-point between the tips of the shoulder and elbow. .	Change from baseline outcome measure at 10th week (post-test)
Primary	Physical examination - calf circumference	Measure participants' calf circumference. The measurement method of the calf circumference should be the same as the shoulder width and place the tape measure at the thickest part of the calf with a horizontal line around it for measurement.	Change from baseline outcome measure at 10th week (post-test)
Primary	Physical examination - hip circumference	Measure participants' hip circumference. The hip measurement method is to use a tape measure to measure the maximum hip diameter.	Change from baseline outcome measure at 10th week (post-test)
Secondary	Physical Activity Questionnaire assessment	Using Physical Activity Questionnaire to assess participants' activity level.	Change from baseline outcome measure at 10th week (post-test)
Secondary	24-hour Dietary Recall Form	The 24-hour diet recall method is conducted by interviewers who have received professional training in food serving size. Ask participants to recall all food and beverages actually consumed in the past 24 hours and record them in the questionnaire. Location, and the name, material, quantity and preparation method of food; among them, the estimation of the quantity can be assisted by using food weighing tools and food quantitative aids.	Change from baseline outcome measure at 10th week (post-test)
Secondary	Gastrointestinal Function Assessment	Assess the number of bowel movements, bowel habits, bowel pattern, and flatulence	Change from baseline outcome measure at 10th week (post-test)
Secondary	Mini nutrition assessment	This Mini nutrition assessment is a Indicator of nutrition status .The score range from 0-30,24 to 30 points represent Normal nutritional status, 17 to 23.5 points represent At the risk of malnutrition, less than 17 points represent Malnourished.	Change from baseline outcome measure at 10th week (post-test)