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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041641
Receipt No. R000047360
Scientific Title Effects of food components on knee joints Placebo-controlled double-blind randomized parallel group comparative study
Date of disclosure of the study information 2020/09/02
Last modified on 2020/09/02

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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 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
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 Open public recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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