UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029871 |
|---|---|
| Receipt number | R000034077 |
| Scientific Title | Clinical study of low molecular Fish collagen peptide. A randomized, placebo-controlled double-blind study using low molecular fish collagen peptide in healthy adults suffering from occasional knee pain and discomfort -Verification of influence on knee joint function by continuous ingestion of low molecular fish collagen peptide- |
| Date of disclosure of the study information | 2017/11/08 |
| Last modified on | 2023/05/15 09:48:46 |
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Basic information
Public title
Clinical study of low molecular Fish collagen peptide.
A randomized, placebo-controlled double-blind study using low molecular fish collagen peptide in healthy adults suffering from occasional knee pain and discomfort
-Verification of influence on knee joint function by continuous ingestion of low molecular fish collagen peptide-
Acronym
Clinical study of low molecular Fish collagen peptide.
Scientific Title
Clinical study of low molecular Fish collagen peptide.
A randomized, placebo-controlled double-blind study using low molecular fish collagen peptide in healthy adults suffering from occasional knee pain and discomfort
-Verification of influence on knee joint function by continuous ingestion of low molecular fish collagen peptide-
Scientific Title:Acronym
Clinical study of low molecular Fish collagen peptide.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the influence of 12weeks ingestion of low molecular fish collagen peptide to the function of knee joint.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
VAS survey
Key secondary outcomes
VAS survey
The knee joint function survey
Life Style survey
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
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
Ingestion of low molecular weight of fish collagen peptide for 12 weeks.
Interventions/Control_2
Ingestion of placebo for 12 weeks.
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
| 45 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.
The age, more than 45 years old, less than 75 years old, Healthy adult male and female.
2.
A joint of the knee is uncomfortable feeling. But Medicine treatment isn't being performed.
3.
The person who is giving written informed consent.
Key exclusion criteria
1.
The person is the knee arthritis and has a medical treatment by a doctor.
The person diagnosed with osteoarthritis of the knee.
2.
The person infected with cerebrovascular disease, a heart disease, a liver disease, a kidney disease and a digestive organ disease
The person who judged that a trouble had the above medical history in clinical test participation
3.
The person is allergy to medication and/or food.
The person diagnosed with atopic dermatitis.
4.
The person who had abnormality in the blood pressure and the laboratory test etc. in a screening.
5.
The person who is taking healthy food and a supplement (hyaluronic acid, glucosamine etc.), and can't stop intake of these in the test duration.
6.
The person who is started new medical treatment within 1week before intake the test food.
The person who is plan to undergo medical treatment on knees during the study.
7.
The person who judged that a test responsibility PI was disqualified.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Director, Mikio Chibana,M.D. |
Organization
OROKU HEART CLINIC
Division name
N.A.
Zip code
Address
1-12-2,Akamine,Nha-shi,Okinawa,901-0154,Japan
TEL
098-852-8080
ren-ccrc@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Director, Mikio Chibana,M.D. |
Organization
OROKU HEART CLINIC
Division name
N.A.
Zip code
Address
1-12-2,Akamine,Nha-shi,Okinawa,901-0154,Japan
TEL
098-852-8080
Homepage URL
ren-ccrc@umin.ac.jp
Sponsor or person
Institute
OROKU HEART CLINIC
Institute
Department
Personal name
Funding Source
Organization
Medicos International,Inc.
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
Address
Tel
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
| 2017 | Year | 11 | Month | 08 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 18 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 03 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 11 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 08 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034077
