UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on influence on peripheral blood flow and cold by intake of fish oil
Title of the study (Brief title)	Study on influence of cold
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Study on influence on peripheral blood flow and cold by intake of fish oil
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in body temperature and peripheral blood flow before ingestion and after ingestion period
Key secondary outcomes	Subjective symptom questionnaire on cold (VAS)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test food: intake of fish oil 2.4g/day, 8 weeks
Interventions/Control_2	Placebo food: intake of corn oil 2.4g/day, 8 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	20 years-old <=
Age-upper limit	49 years-old >=
Gender	Female
Key inclusion criteria	1) Japanese females aged 20 to 49 years old at the time of acquiring consent 2) Persons who are sensitive to cold
Key exclusion criteria	During pregnancy or possibly pregnant, and those who are breastfeeding Persons who are likely to have allergic symptoms due to the tested component Persons participating in other clinical trials Persons who have a history of serious liver disorder, kidney disorder, heart disease Persons who have a history of gastrointestinal disease Persons who are taking medicine for digestive system diseases Persons who have a long history of medical illness Smoker Persons who have a history of frostbite or who currently suffer Persons who eat blue fish (maize, mackerel, sardine, saury, etc) for more than 4 days a week Persons who are taking medicines (such as pharmaceuticals based on ethyl icosapentate) or supplements (EPA, DHA, hesperidin, capsaicin, ginger extract, Hiichatsu etc.) that have an influence on the test results Persons who have consciousness of menopausal disorder Alcoholic drinkers (eg everyday, 3 or more beer bottles) Persons with menstrual irregularity Persons with irregular lifestyle (timing of meals is not fixed, insufficient sleep etc.) Persons with irregular shift work and late night work Persons who are suffering from specific diseases and who are visiting hospital, medication or treatment Persons who exercise for over an hour every day
Target sample size	30

Research contact person
Name of lead principal investigator	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
Address	6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1590
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	Ko MASUDA
Organization	SOUKEN Co., Ltd
Division name	Management Division
Address	3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL	03-5408-1555
Homepage URL
Email	k_masuda@mail.souken-r.com

Sponsor
Institute	Shiba Palace Clinic
Institute
Department

Funding Source
Organization	Nippon Suisan Kaisha, Ltd.,
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 01 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 22 Day
Anticipated trial start date	2018 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 12 Month 29 Day
Last modified on	2018 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034982