UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040810 |
|---|---|
| Receipt number | R000046591 |
| Scientific Title | Effects of amino acids-enriched food in healthy adults with discomfort in knee joint: Placebo-control double blind parallel-group comparative study |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2021/06/05 22:52:11 |
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Basic information
Public title
Effect of amino acids-enriched food on knee joint
Acronym
Effect of amino acids-enriched food on knee joint
Scientific Title
Effects of amino acids-enriched food in healthy adults with discomfort in knee joint: Placebo-control double blind parallel-group comparative study
Scientific Title:Acronym
Effects of amino acids-enriched food in healthy adults with discomfort in knee joint
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of amino acids-enriched food on knee joint
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JOA score
JKOM
Visual Analogue Scale (VAS)
Key secondary outcomes
CTX-II, C2C, TNF-alpha, uric acid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Amino acids
Interventions/Control_2
Placebo
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female aged 20 or higher and less than 65 years old.
2. Individuals who were diagnosed with 0 or I in K-L grade by principal investigator at the screening test.
3. Individuals who are living normally but have discomfort in knee joint.
4. Individuals who can make self-judgment and voluntarily provides written informed consent.
Key exclusion criteria
1. Individuals who have a history of rheumatoid arthritis(RA) and have possibility of RA judged by blood marker test at the screening test.
2. Individuals who were diagnosed with osteoarthritis in need of a treatment.
3. Individuals who have implanted artificial joint.
4. Individuals who are under medications which may affect knee joint such as poultice, ointment or painkiller.
5. Individuals who have joint dysfunctions such as meniscus injury or are under the treatment for those dysfunctions.
6. Individuals who have received surgeries for chronic pain on the knee in the past.
7. Individuals who are impossible to stop taking supplements or functional foods which may affect knee joint during this study.
8. Subjects who take amino acid -related medicines such as Aminoleban
9. Individuals who regularly take amino acid/protein supplements.
10. Individuals who have amino acid metabolism disorders.
11. Subjects who are pregnant, lactating or have these plans.
12. Individuals who received more than 200 mL of blood collection within 12 weeks from the screening test.
13. Subject who have participated in a study using other food intake or medicines, and cosmetics within one month retrospectively from the time of obtaining consent, or who are participating in other examinations during this study participation.
14. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Kobuna |
Organization
Kobuna Orthopedic Surgical Clinic
Division name
Director
Zip code
371-081
Address
311-2 Gokan-machi, Maebashi-shi, Gunma-ken, Japan
TEL
027-261-7600
info@kobunaseikei.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales Department
Zip code
105-0023
Address
Shibaura OMODAKA Bldg. 7F, 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO corporation
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co.,Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional ethical review board of Kobuna Orthopedic Surgical Clinic
Address
311-2 Gokan-machi, Maebashi-shi, Gunma-ken, Japan
Tel
027-212-5608
sagawa@mc-connect.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人公雄会 こぶな整形外科医院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 17 | Day |
Last modified on
| 2021 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046591
