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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030637
Receipt No. R000034982
Scientific Title Study on influence on peripheral blood flow and cold by intake of fish oil
Date of disclosure of the study information 2018/01/10
Last modified on 2018/12/26

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Basic information
Public title Study on influence on peripheral blood flow and cold by intake of fish oil
Acronym Study on influence of cold
Scientific Title Study on influence on peripheral blood flow and cold by intake of fish oil
Scientific Title:Acronym 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
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
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
1st name
Middle name
Last name Ko MASUDA
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 11 Month 22 Day
Date of IRB
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

Other
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

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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