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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004518
Receipt No. R000005403
Scientific Title The effect of fish oil supplementation on physiological responses during mental stress
Date of disclosure of the study information 2010/11/08
Last modified on 2012/04/29

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Basic information
Public title The effect of fish oil supplementation on physiological responses during mental stress
Acronym The effect of fish oil supplementation on physiological responses during mental stress
Scientific Title The effect of fish oil supplementation on physiological responses during mental stress
Scientific Title:Acronym The effect of fish oil supplementation on physiological responses during mental stress
Region
Japan

Condition
Condition coronary heart disease
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether fish oil supplementation reduces physiological responses during mental stress
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes heart rate and blood pressure [before and after 12 weeks supplementation]
Key secondary outcomes 1. Cardiovascular indices [before and after 12 weeks supplementation]
- Cardiac output
- Stroke volume
- Total peripheral resistance
- Pre-ejection period
- Normalized pulse volume
- Baroreceptor reflex sensitivity
- Arterial stiffness
2. Neuroendocrinological indices [before and after 12 weeks supplementation]
- Salivary cortisol
- Salivary MHPG
3. Neuroimmunological index [before and after 12 weeks supplementation]
- Salivary Ig-A
4. Subjective ratings [before and after 12 weeks supplementation]
- Subjective ratings to stressful tasks
5. Behavioral indices [before and after 12 weeks supplementation]
- Task performance
- Recall performance of Cahill's script
6. Psychological indices [before and after 12 weeks supplementation]
- Buss-Perry Aggression Questionnaire,
- Behavioral Inhibition/Activation System Scale
- Short-Form Eysenck Personality Questionnarie-Revised
- Lee's Type Scale 2nd version (love attitude scale)
- State-Trait Anxiety Inventory
7. Blood [before and after 12 weeks supplementation]
- Omega-3 and -6 concentrations in red blood cells

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 1. Experimental
A capsule of omega-3 Polyunsaturated Fatty Acid, 300mg (including 15% docosahexaenoic acid, 40% eicosapentaenoic acid and other), 12 capsules per day in 12 week.
Interventions/Control_2 2. Placebo
A capsule of other Polyunsaturated Fatty Acid, 300mg (including 47% canola oil, 25% soybean oil, 25% olive oil and 3% fish oil), 12 capsules per day in 12 week.
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
39 years-old >=
Gender Male and Female
Key inclusion criteria 1. 20 - 39 years old
2. A native Japanese speaking ability
3. Physical and metal status to possible understands scope and contents in the trial and gets informed consent
Key exclusion criteria 1. Heavy drinker
2. Heavy smoker (over 40 cigarettes per day)
3. Habit of eating fish over 4 times per week
4. Use of polyunsaturated fatty acid supplement within 3 month at regular intervals
5. Current suspicion in coronary heart disease, hypertension (resting blood pressure greater than 160/100 mmHg), diabetes and pregnancy
6. Use of anti-epilepsy drug, lithium, ethyl icosapentate and anti-coagulant drug (for example, aspirin, warfarin, etc) within 3 month at regular intervals
7. History and current suspicion in diagnosis of psychosis, bipolar I disorder, alcoholic, substance-related disorder and eating disorder
Target sample size 28

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenta Matsumura
Organization College of Science and Engineering, Kanazawa University
Division name School of Mechanical Engineering
Zip code
Address Kakuma-cho, Kanazawa, Ishikawa
TEL 076-264-6467
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenta Matsumura
Organization College of Science and Engineering, Kanazawa University
Division name School of Mechanical Engineering
Zip code
Address
TEL
Homepage URL
Email kenta16moon@se.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Toyama University, Kurume University, Kanazawa University, Disaster Medical Center
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 独立行政法人国立病院機構災害医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 08 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
2010 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 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
2010 Year 11 Month 08 Day
Last modified on
2012 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005403

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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