UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Yoshihiko Mano
Organization	Sendai University
Division name	Facultyl of Physical Education
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	Yoshihiko Mano
Organization	Sendai University
Division name	Faculty of Physical Education
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032814