UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006775 |
|---|---|
| Receipt number | R000008012 |
| Scientific Title | Psychophysiological evaluation of effect of ingestion of oil extracted from krill on brain function |
| Date of disclosure of the study information | 2011/12/20 |
| Last modified on | 2011/12/18 00:22:38 |
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Basic information
Public title
Psychophysiological evaluation of effect of ingestion of oil extracted from krill on brain function
Acronym
Psychophysiological evaluation of effect of krill oil on brain function
Scientific Title
Psychophysiological evaluation of effect of ingestion of oil extracted from krill on brain function
Scientific Title:Acronym
Psychophysiological evaluation of effect of krill oil on brain function
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the aim of investigating the influence of long-term ingestion of krill oil on brain function, we use near-infrared spectroscopy to measure changes in the concentration of oxy-hemoglobin, which is an indicator of activation of brain function. We also record the event-related potential obtained from the analysis of electroencephalogram.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Before starting ingestion, at week 6 and 12,
1) the changes in the oxy-Hb concentration during calculation tasks, and results of performance
2) the changes in oxy-Hb concentration and ERP during memory tasks, and results of performance
3) psychological tests by using POMS, STAI, and the visual analog scale (VAS)
Key secondary outcomes
Before starting ingestion, at week 6 and 12,
1) height, weight, and blood pressure
2) results of blood test (white blood cell count, red blood cell count, hemoglobin, and hematocrit)
3) results of blood biochemical test (GOT, GPT, gamma-GTP, creatinine, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, blood sugar, HbA1c, and uric acid)
4) fatty acids in plasma (dihomo-gamma linorenic acid, arachidonic acid, EPA, and DHA)
5) results of urine test (occult blood, urinary protein, urinary sugar, and urobilinogen)
6) nutrient intake by food frequency method
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
sample: krill oil
dose: 2g/day
period: 12weeks
Interventions/Control_2
sample: sardine oil
dose: 2g/day
period: 12weeks
Interventions/Control_3
sample: middle-chain triglycerides (placebo)
dose: 2g/day
period: 12weeks
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
| 60 | years-old | <= |
Age-upper limit
| 73 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy and right-handed
Key exclusion criteria
1) administration of regular medication
2) history of mental disorder or cerebrovascular disease
3) serious liver, kidney, heart, respiratory, endocrine, or metabolic diseases
4) marked abnormal findings for results of blood and urine tests
5) food allergies to fish or crustaceans
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Koga |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Koga |
Organization
Kyorin University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422-47-5511
Homepage URL
koga@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nippon Suisan Kaisya Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
杏林大学医学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In the case of memory task, the changes in the oxy-Hb concentrations of the sardine oil and the krill oil groups were significantly greater compared with those of the placebo group at week 12. Regarding ERP, P300 latency of the krill oil group was significantly shorter than that of the placebo group at week 12. About the calculation task, in the krill oil group, the changes in the oxy-Hb concentrations were significantly greater at week 12 than those at week 0. (The 13th Congress of Japan Human Brain Mapping Society)
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 | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 25 | Day |
Last modified on
| 2011 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008012
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