Koji Product Supplementation' s Study

Not Applicable

Completed

• Conditions: Sarcopenia
• Interventions: Dietary Supplement: Black soybean koji product

• Registration Number: NCT04951843
• Lead Sponsor: National Taiwan University Hospital

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 Timeline

• Study Start: 2018-10-12
• Study First Submitted: 2019-04-15
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-27
• Last Update Submitted: 2021-06-27
• Study First Posted: 2021-07-07
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Black soybean koji product	Black soybean koji product	Oral supplement 2 servings of black soybean koji product per day, for 10 weeks.

Primary Outcome Measures

Name	Time	Method
Triglyceride analysis	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)	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	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	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	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	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of HbA1C(%).
Fasting blood glucose analysis	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	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	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	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	Change from baseline outcome measure at 10th week (post-test)	Using hand grips to measure hand grip strength.
Physical Performance - Walking Speed	Change from baseline outcome measure at 10th week (post-test)	Measuring participants' speed to walk 5 ft.
Red blood cells analysis	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	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of MCHC(g/dL)
Hematocrit analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of Hematocrit(%).
AST analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of AST(U/L).
GGT analysis	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)	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	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	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	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	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of Hemoglobin(g/dL).
Albumin analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of albumin(g/dL).
Body mass index	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	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	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	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	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of RDW-CV(%).
MCH analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of MCH(pg).
ALT analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of ALT(U/L).
T-Cholesterol analysis	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	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of LDL-C(mg/dL).
Creatinine analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of creatinine(mg/dL).
Ca analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of Ca(mmol/dL).
Urine pH analysis	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	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	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of MCV(fL).
Platelets analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of Platelets(k/uL).
WBC analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of WBC(k/uL) .
HDL-C analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of HDL-C(mg/dL).
eGFR analysis	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	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	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	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of BUN(mg/dL).
hs-CRP analysis	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	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	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of 【 HOMA-IR】
specific gravity index analysis	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	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	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	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	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	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	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	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	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	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of Uric acid(mg/dL).
hsTSH analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of 【hsTSH(ulU/dL)】
Insulin analysis	Change from baseline outcome measure at 10th week (post-test)	Use the Clinical Chemistry Analyzer to detection of 【 insulin(uU/dL)】
Urine bilirubin (dipstick) analysis	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
24-hour Dietary Recall Form	Change from baseline outcome measure at 10th week (post-test)	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.
Physical Activity Questionnaire assessment	Change from baseline outcome measure at 10th week (post-test)	Using Physical Activity Questionnaire to assess participants' activity level.
Gastrointestinal Function Assessment	Change from baseline outcome measure at 10th week (post-test)	Assess the number of bowel movements, bowel habits, bowel pattern, and flatulence
Mini nutrition assessment	Change from baseline outcome measure at 10th week (post-test)	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.

Trial Locations

Locations (1)

Taipei Medical University; 🇨🇳 Taipei City, Taiwan