UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027732 |
|---|---|
| Receipt number | R000031763 |
| Scientific Title | A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract including proteoglycan |
| Date of disclosure of the study information | 2017/06/13 |
| Last modified on | 2017/06/12 17:37:46 |
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Basic information
Public title
A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract including proteoglycan
Acronym
A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract
Scientific Title
A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract including proteoglycan
Scientific Title:Acronym
A clinical study for evaluating the safety of excessive intake of salmon nasal cartilage extract
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive intake of salmon nasal cartilage extract for 4 weeks in healthy adults.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematologic test
Biochemistry test
Urinalysis
Medical interview
Adverse event
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of salmon nasal cartilage extract,
5 fold quantity of recommended daily intake, for 4 weeks.
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy men and women.
2) Subjects giving written informed consent based on Declaration of Helsinki.
3) Subjects who can intake test food sample every day during test period.
4) Subjects who can attend to every examinations.
Key exclusion criteria
1) Subjects who take drugs or supplements
2) Subjects undergoing treatment for some serious disorders
3) Subjects who make a blood donation within the last month before and during the test
4) Women who are pregnant or breast-feeding
5) Subjects who have allergies to salmon, shrimp or crab
6) Subjects whose participation is deemed inappropriate by pilot questionnaire, clinical test values or physical exam values
7) Subjects who cannot follow a guideline of test
8) Subjects undergoing hormone replacement therapy
9) Subjects whose participation is deemed inappropriate by a test director
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazue Takayama |
Organization
Ichimaru Pharcos Co., Ltd.
Division name
Product Development
Zip code
Address
318-1 Asagi, Motosu-Shi, Gifu 501-0475 Japan
TEL
058-320-1036
takayama-kazue@ichimaru.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazunori Enya |
Organization
Ichimaru Pharcos Co., Ltd.
Division name
Product Development
Zip code
Address
318-1 Asagi, Motosu-Shi, Gifu 501-0475 Japan
TEL
058-320-1037
Homepage URL
enya-kazunori@ichimaru.co.jp
Sponsor or person
Institute
Ichimaru Pharcos Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ichimaru Pharcos Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
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
独立行政法人地域医療機能推進機構 可児とうのう病院 健康管理センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 13 | 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
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 12 | Day |
Last modified on
| 2017 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031763
