UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030637 |
|---|---|
| Receipt number | 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 18:59:01 |
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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
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
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034982
