UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031251 |
|---|---|
| Receipt number | R000035684 |
| Scientific Title | Safety evaluation of salmon extract containing anserine |
| Date of disclosure of the study information | 2018/02/12 |
| Last modified on | 2019/08/23 14:06:22 |
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Basic information
Public title
Safety evaluation of salmon extract containing anserine
Acronym
Safety evaluation of salmon extract containing anserine
Scientific Title
Safety evaluation of salmon extract containing anserine
Scientific Title:Acronym
Safety evaluation of salmon extract containing anserine
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the safety when salmon extract is ingested continuously for 3.3 g / day (1 g as anserine) for 30 days.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety : Adverse effects
Key secondary outcomes
hematological test (WBC, RBC, Hb, Ht, and Plt), blood biochemical test (AST, ALT, gamma-GTP, ALP, ALB, serum amylase, TC, LDL-C, HDL-C, TG, fasting blood glucose, HbA1c, UA, CRE, BUN and CRP) before ingestion and after 30 days
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
Ingestion of 3.3 g / day of salmon extract (1 g as anserine) for 30 days
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy middle-to-elderly volunteer.
2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1) Subjects who have total serum cholesterol over 260 mg/dL.
2) Subjects who have ALT, AST and gamma-GTP more than twice the standard value.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shigenobu |
| Middle name | |
| Last name | Shiotani |
Organization
Tokaibussan Co., Ltd
Division name
research division
Zip code
437-0012
Address
2391 Kunimoto, Fukuroi City, Shizuoka, JAPAN 437-0012
TEL
0538-42-1410
shiotani@tokaibsn.co.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Sato |
Organization
Tokaibussan Co., Ltd
Division name
Sales department
Zip code
101-0032
Address
1-10-5 Iwamotocho, Tokyo, JAPAN 101-0032
TEL
03-3864-6861
Homepage URL
sato@tokaibsn.co.jp
Sponsor or person
Institute
Tokaibussan Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Tokaibussan 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
Tokai Bussan Co., Ltd. Ethics Committee
Address
1-10-5 Iwamotocho, Tokyo, JAPAN 101-0032
Tel
03-3864-6861
h-nagata@tokaibsn.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
小川町メディカルクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 12 | 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
11
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
| 2018 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 11 | Day |
Last modified on
| 2019 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035684
