UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028795 |
|---|---|
| Receipt number | 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 09:06:37 |
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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
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
ys-mano@sendai-u.ac.jp
Sponsor or person
Institute
Sendai University
Faculty of Physical Education
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032814
