UMIN-CTR Clinical Trial

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