UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000039824
Receipt No. 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 (Ver. 8)

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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
Email 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
Email saki_okumura@n1.noevir.co.jp

Sponsor
Institute Noevir Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045374