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Completed

NCT Number: NCT04951843

Koji Product Supplementation' s Study

The present project is to identify the effect of black soy beans Koji product supplementation on nutrients absorption and anti-aging effect in elderly.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

Taipei, 110, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1-2 items are necessary, 3-5 can match one item
  • Age above 65 years
  • Oral intake
  • Walking speed: ≤ 0.8 m/s (measured by time for a 5-meter usual gait)
  • Handgrip strength: Men: <26 kg Women: <18 kg (measured by electronic hand grip dynamometer)
  • Calf circumference: Men: ≤ 34 cm Women: ≤ 33 cm

Exclusion criteria

  • Participant in a moderate or strenuous exercise
  • Unable to walk
  • Unable to take in food from the mouth
  • People who can't record or communicate.
  • Refuse to accept the 3-day diet record
  • Allergic to black soybeans or legumes
  • Allergic to egg or milk
  • Infected with disease and had to be hospitalized for treatment before 4 weeks of the intervention test start
  • A patient who has been diagnosed with a malignant tumor or has a history of malignancy in the past year.
  • The estimated glomerular filtration rate (eGFR) is less than 60 ml/min/1.73 m2 in the past three months.
  • Hypothyroidism
  • People who often have symptoms of gastrointestinal upset.

Treatment and study plan

Black soybean koji product

Dietary Supplement

Black soybean koji product

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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).

  5. 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)

    .

  6. 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.

    .

  7. 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).

  8. 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.

    .

  9. 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.

  10. Physical Performance - Walking Speed

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

    Measuring participants' speed to walk 5 ft.

  11. 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).

  12. 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.

  13. 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).

  14. 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).

  15. 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).

  16. 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)

  17. 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).

  18. 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)

  19. 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).

  20. Hematocrit analysis

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

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

  21. 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(%).

  22. HbA1C analysis

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

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

  23. MCV analysis

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

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

  24. MCH analysis

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

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

  25. 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).

  26. 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) .

  27. 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).

  28. 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).

  29. 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).

  30. 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).

  31. 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).

  32. 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).

  33. 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).

  34. 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).

  35. 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).

  36. 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).

  37. 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).

  38. 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).

  39. 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)】

  40. 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)】

  41. 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】

  42. 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)】

  43. 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)】

  44. 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).

  45. 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).

  46. 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.

  47. 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).

  48. 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 (-/+).

  49. 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(-/+).

  50. 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(-/+).

  51. 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).

  52. 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 (-/+).

  53. 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).

  54. 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).

  55. 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(-/+).

  56. 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(-/+).

  57. 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.

  58. 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..

  59. 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..

  60. 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.

  61. 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.

  62. 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.

  63. 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. .

  64. 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.

  65. Physical examination - hip circumference

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

    Measure participants' hip circumference. The hip measurement method is to use a tape measure to measure the maximum hip diameter.

Secondary outcomes

  1. Physical Activity Questionnaire assessment

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

    Using Physical Activity Questionnaire to assess participants' activity level.

  2. 24-hour Dietary Recall Form

    Time frame: 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.

  3. Gastrointestinal Function Assessment

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

    Assess the number of bowel movements, bowel habits, bowel pattern, and flatulence

  4. Mini nutrition assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Ministry of Science and Technology, Taiwan
  • Taipei Medical University

Registry information

Official study title

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

Acronym: KPS

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 7, 2021
Registry last updated
Jul 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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