UMIN-CTR Clinical Trial

Basic information
Public title	Effects of food components on knee joints Placebo-controlled double-blind randomized parallel group comparative study
Acronym	Effects of food components on knee joints Placebo-controlled double-blind randomized parallel group comparative study
Scientific Title	Effects of food components on knee joints Placebo-controlled double-blind randomized parallel group comparative study
Scientific Title:Acronym	Effects of food components on knee joints Placebo-controlled double-blind randomized parallel group comparative study
Region	Japan

Condition
Condition	Healthy person
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We examined the effects of the test food on the type II collagen degradation marker, type II collagen synthesis marker, and cartilage type II collagen degradation marker before and after ingestion of the test food for 16 weeks in healthy adult men and women with discomfort in the knee.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluated by the subject (JKOM and VAS )
Key secondary outcomes	Markers for collagen(C1,2C, CPII, CTX-II)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Collagen from fish
Interventions/Control_2	Non-denatured collagen from fish
Interventions/Control_3	placebo
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	40 years-old <=
Age-upper limit	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Men and women whose age at the time of obtaining consent is 40 to 70 years old 2) People with discomfort in their knees 3) Kellgren-Lawrence (K-L) classification grade 0-2 4) Those who have sufficiently explained the purpose and contents of the research, have the ability to agree, have volunteered to participate in the test after understanding it well, and consented to the test in writing.
Key exclusion criteria	1. with hyperuricemia and gout attack 2.Providing medical and physical therapy treatments for knees 3.Person who has a history of knee surgery or knee surgery is necessary 4.We regularly use health foods that affect the test results and continue to take them during the test period. 5. I regularly use drugs that affect the evaluation of this study. 6. Ingestion of drugs that affect bone metabolism markers 7.Intra-articular injection of hyaluronic acid or steroids 8. Need joint drug therapy during the test period 9. Surgery planned regardless of knee during the test period 10. Routine physical activity 11. History of bone and joint related diseases such as fractures and sprains within the past 3 months 12. Those who are judged to be unsuitable as subjects from the answers to the lifestyle habits 13. Disqualification as a result of clinical laboratory test 14. Taking warfarin due to cerebral infarction or heart disease 15. Test food may cause allergies 16. History of malignant tumor 17. Lactating, pregnant, and planning to become pregnant during the study 18. Participating in other clinical trials at the start of this study 19. In addition, the investigator determined that the patient was ineligible
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Hideharu Middle name Last name Nakano
Organization	Linise Co., Ltd
Division name	CEO
Zip code	001-0021
Address	Nishi12, Kita 21, kitaku, Sapporo, Hokkaido
TEL	011-374-7118
Email	info@linise.co.jp

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Otake
Organization	feileB Co.Ltd
Division name	Clinical Trial Support Department
Zip code	160-0015
Address	22-1, Daikyo-cho, Shinjuku-ku, Tokyo
TEL	03-6416-4228
Homepage URL
Email	otake@feileb.jp

Sponsor
Institute	Linise Co., Ltd
Institute
Department

Funding Source
Organization	Linise Co., Ltd
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	AMC Nishi-Umeda Clinic Ethical Review Committee
Address	Maruito West Umeda Building 3F 3-3-45 Umeda Kita-ku Osaka Japan,530-0001
Tel	06-4797-5660
Email	jimukyoku@amc-clinc.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

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 02 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	74
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 07 Month 01 Day
Date of IRB	2020 Year 07 Month 17 Day
Anticipated trial start date	2020 Year 08 Month 20 Day
Last follow-up date	2020 Year 12 Month 28 Day
Date of closure to data entry	2021 Year 03 Month 01 Day
Date trial data considered complete	2021 Year 04 Month 15 Day
Date analysis concluded	2021 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2020 Year 09 Month 02 Day
Last modified on	2021 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047360