UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039824 |
|---|---|
| Receipt number | R000045374 |
| Scientific Title | Verification of the improvement effect of simultaneous intake of proteoglycan derived from the salmon bone cartilage, non-denatured type II collagen derived from the salmon nasal cartilage, and olive-leaf extract on the knee joint and skin quality |
| Date of disclosure of the study information | 2020/03/23 |
| Last modified on | 2020/08/25 15:01:45 |
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Basic information
Public title
Verification of the improvement effect of simultaneous intake of proteoglycan derived from the salmon bone cartilage, non-denatured type II collagen derived from the salmon nasal cartilage, and olive-leaf extract on the knee joint and skin quality
Acronym
Verification of the improvement effect of simultaneous intake of proteoglycan derived from the salmon bone cartilage, non-denatured type II collagen derived from the salmon nasal cartilage, and olive-leaf extract on the knee joint and skin quality
Scientific Title
Verification of the improvement effect of simultaneous intake of proteoglycan derived from the salmon bone cartilage, non-denatured type II collagen derived from the salmon nasal cartilage, and olive-leaf extract on the knee joint and skin quality
Scientific Title:Acronym
Verification of the improvement effect of simultaneous intake of proteoglycan derived from the salmon bone cartilage, non-denatured type II collagen derived from the salmon nasal cartilage, and olive-leaf extract on the knee joint and skin quality
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the improvement effect of simultaneous intake of proteoglycan derived from the salmon bone cartilage, non-denatured type II collagen derived from the salmon nasal cartilage, and olive-leaf extract on the knee joint and skin quality
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For 12 weeks from the initiation of inoculation,Four measurement points:Day 0,Day 28, Day 56, and Day 84
Body constituents Body compositions (body weight, body fat, volume of water,
muscle mass, etc.)
Skin measurement 1,Volume of water, 2,TEWL, 3,Viscoelasticity, 4,Photography
Questionnaire Knee joint, feeling of effect on the skin, daily life
Key secondary outcomes
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
joint supplement intake
For 12 weeks from the initiation of inoculation,Four measurement points:Day 0,Day 28, Day 56, and Day 84
Interventions/Control_2
placebo control intake
For 12 weeks from the initiation of inoculation,Four measurement points:Day 0,Day 28, Day 56, and Day 84
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
| 50 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
1,The age at the time of obtaining a conesent is 20 years or older
2,Female
3,Those from whom a written consent can be obtained on a voluntary basis.
Key exclusion criteria
The person who is unsuitable for the entry judged by a ficer
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | SHINGAKI |
Organization
Noevir Co., Ltd.
Division name
Groupwide Research and Development
Zip code
213-0012
Address
R&D C Building No. 333, Kanagawa Science park (KSP), 3-2-1 Sakado, Takatsu-ku, Kawasaki-shi, Kanagaw
TEL
044-813-2488
nb4208@n1.noevir.co.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | OKUMURA |
Organization
Noevir Co., Ltd.
Division name
Groupwide Research and Development
Zip code
213-0012
Address
R&D C Building No. 333, Kanagawa Science park (KSP), 3-2-1 Sakado, Takatsu-ku, Kawasaki-shi, Kanagaw
TEL
044-813-2488
Homepage URL
saki_okumura@n1.noevir.co.jp
Sponsor or person
Institute
Noevir Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Noevir 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
Noevir Co., Ltd. IRB
Address
112-1 Okadacho, Higashiomi City, Shiga Prefecture
Tel
0748-23-6810
n98213@n1.noevir.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 23 | 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
27
Results
Significant improvements in knee joint and skin quality was observed in the joint supplement intake group.
Results date posted
| 2020 | Year | 08 | Month | 25 | Day |
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 | 02 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 19 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 24 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 16 | Day |
Last modified on
| 2020 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045374
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