UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004518 |
|---|---|
| Receipt number | 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 05:53:58 |
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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
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
kenta16moon@se.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005403
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
