UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041641 |
|---|---|
| Receipt number | 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 | 2021/05/28 18:49:10 |
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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
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
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
otake@feileb.jp
Sponsor or person
Institute
Linise Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047360
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