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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031251
Receipt No. 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

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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
Email 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
Email sato@tokaibsn.co.jp

Sponsor
Institute Tokaibussan Co., Ltd
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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