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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028795
Receipt No. R000032814
Scientific Title The effect of ingestion of eicosapentaenoic acid-rich fish oil on oxidative stress at the menstrual phase : a randomized, double-blind, placebo-controlled, parallel-group trial.
Date of disclosure of the study information 2017/08/30
Last modified on 2018/08/28

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Basic information
Public title The effect of ingestion of eicosapentaenoic acid-rich fish oil on oxidative stress at the menstrual phase : a randomized, double-blind, placebo-controlled, parallel-group trial.
Acronym The effect of eicosapentaenoic acid on oxidative stress at the menstrual phase.
Scientific Title The effect of ingestion of eicosapentaenoic acid-rich fish oil on oxidative stress at the menstrual phase : a randomized, double-blind, placebo-controlled, parallel-group trial.
Scientific Title:Acronym The effect of eicosapentaenoic acid on oxidative stress at the menstrual phase.
Region
Japan

Condition
Condition oxidative stress
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is investigating the influence of eicosapentaenoic acid ( EPA ) for oxidative stress at the menstrual phase in women with the regular menstrual cycles.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Derivatives of reactive oxygen metabolites ( d-ROMs ) and biological antioxidant potential ( BAP ) in blood at the menstrual and follicular phase
Key secondary outcomes The menstrual discomfort measured as subjective evaluation before and during the menstruation

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 Tested material: EPA-rich fish oil
Dosage: 3.6g/day
Duration: consecutive two menstrual cycles
Interventions/Control_2 Tested material: corn oil
Dosage: 3.6g/day
Duration: consecutive two menstrual cycles
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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Healthy women subjects with the regular menstrual cycles
Key exclusion criteria Subjects with
/ gynecological diseases /the menstrual discomfort as serious as needing medication /fish such as sardine or mackerel allergies /administration of regular medication or supplements which affect this study / smoker /any reason in the opinion of the lead principal investigator not to be taken part in this study
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Mano
Organization Sendai University
Division name Facultyl of Physical Education
Zip code
Address 2-2-18 Funaokaminami, Shibata-cho, Shibata-gun, Miyagi, Japan
TEL 0224-55-1389
Email ys-mano@sendai-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiko Mano
Organization Sendai University
Division name Faculty of Physical Education
Zip code
Address 2-2-18 Funaokaminami, Shibata-cho, Shibata-gun, Miyagi, Japan
TEL 0224-55-1389
Homepage URL
Email ys-mano@sendai-u.ac.jp

Sponsor
Institute Sendai University
Faculty of Physical Education
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 仙台大学体育学部(宮城県)
(Sendai University Faculty of Physical Education)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 30 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 08 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 30 Day
Last follow-up date
2018 Year 02 Month 15 Day
Date of closure to data entry
2018 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 23 Day
Last modified on
2018 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032814

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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