UMIN-CTR Clinical Trial

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
Email	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
Email	yoshi@kso.co.jp

Sponsor
Institute	KSO corporation
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046591