Koji Product Supplementation' s Study

NCT04951843 | Completed

• 1 other identifier: 201806058RINA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

protein

Outcome Measures

Primary Outcomes (65)

• 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)

• 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).

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• Muscle Strength - Hand Grip Strength

  Using hand grips to measure hand grip strength.

  Change from baseline outcome measure at 10th week (post-test)

• Physical Performance - Walking Speed

  Measuring participants' speed to walk 5 ft.

  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).

  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.

  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).

  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).

  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).

  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)

  Change from baseline outcome measure at 10th week (post-test)

• Hemoglobin analysis

  Use the Clinical Chemistry Analyzer to detection of Hemoglobin(g/dL).

  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)

  Change from baseline outcome measure at 10th week (post-test)

• Albumin analysis

  Use the Clinical Chemistry Analyzer to detection of albumin(g/dL).

  Change from baseline outcome measure at 10th week (post-test)

• Hematocrit analysis

  Use the Clinical Chemistry Analyzer to detection of Hematocrit(%).

  Change from baseline outcome measure at 10th week (post-test)

• RDW-CV analysis

  Use the Clinical Chemistry Analyzer to detection of RDW-CV(%).

  Change from baseline outcome measure at 10th week (post-test)

• HbA1C analysis

  Use the Clinical Chemistry Analyzer to detection of HbA1C(%).

  Change from baseline outcome measure at 10th week (post-test)

• MCV analysis

  Use the Clinical Chemistry Analyzer to detection of MCV(fL).

  Change from baseline outcome measure at 10th week (post-test)

• MCH analysis

  Use the Clinical Chemistry Analyzer to detection of MCH(pg).

  Change from baseline outcome measure at 10th week (post-test)

• Platelets analysis

  Use the Clinical Chemistry Analyzer to detection of Platelets(k/uL).

  Change from baseline outcome measure at 10th week (post-test)

• WBC analysis

  Use the Clinical Chemistry Analyzer to detection of WBC(k/uL) .

  Change from baseline outcome measure at 10th week (post-test)

• AST analysis

  Use the Clinical Chemistry Analyzer to detection of AST(U/L).

  Change from baseline outcome measure at 10th week (post-test)

• ALT analysis

  Use the Clinical Chemistry Analyzer to detection of ALT(U/L).

  Change from baseline outcome measure at 10th week (post-test)

• GGT analysis

  Use the Clinical Chemistry Analyzer to detection of GGT(U/L).

  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).

  Change from baseline outcome measure at 10th week (post-test)

• Triglyceride analysis

  Use the Clinical Chemistry Analyzer to detection of triglyceride(mg/dL).

  Change from baseline outcome measure at 10th week (post-test)

• BUN analysis

  Use the Clinical Chemistry Analyzer to detection of BUN(mg/dL).

  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).

  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).

  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).

  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).

  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).

  Change from baseline outcome measure at 10th week (post-test)

• Creatinine analysis

  Use the Clinical Chemistry Analyzer to detection of creatinine(mg/dL).

  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)】

  Change from baseline outcome measure at 10th week (post-test)

• hsTSH analysis

  Use the Clinical Chemistry Analyzer to detection of 【hsTSH(ulU/dL)】

  Change from baseline outcome measure at 10th week (post-test)

• HOMA-IR analysis

  Use the Clinical Chemistry Analyzer to detection of 【 HOMA-IR】

  Change from baseline outcome measure at 10th week (post-test)

• Insulin analysis

  Use the Clinical Chemistry Analyzer to detection of 【 insulin(uU/dL)】

  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)】

  Change from baseline outcome measure at 10th week (post-test)

• Ca analysis

  Use the Clinical Chemistry Analyzer to detection of Ca(mmol/dL).

  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).

  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.

  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).

  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 (-/+).

  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(-/+).

  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(-/+).

  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).

  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 (-/+).

  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).

  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).

  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(-/+).

  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(-/+).

  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.

  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..

  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..

  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.

  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.

  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.

  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. .

  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.

  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.

  Change from baseline outcome measure at 10th week (post-test)

Secondary Outcomes (4)

• 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)

Study Arms (1)

Black soybean koji product

EXPERIMENTAL

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

Dietary Supplement: Black soybean koji product

Interventions

Black soybean koji product DIETARY_SUPPLEMENT

Black soybean koji product

Black soybean koji product

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator
• Taipei Medical University: collaborator

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Hui-Yu Huang, Ph.D

  Taipei Medical University Graduate Institute of Metabolism and Obesity Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: July 7, 2021
• Study Start: October 12, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 7, 2021

Record last verified: 2021-06

Locations

TW (1)