UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039901 |
|---|---|
| Receipt number | R000045507 |
| Scientific Title | Long term flaxseed consumption for cognitive function in the elderly |
| Date of disclosure of the study information | 2020/03/24 |
| Last modified on | 2022/03/25 15:55:37 |
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Basic information
Public title
Long term flaxseed consumption for cognitive function in the elderly
Acronym
Long term flaxseed consumption for cognitive function in the elderly
Scientific Title
Long term flaxseed consumption for cognitive function in the elderly
Scientific Title:Acronym
Long term flaxseed consumption for cognitive function in the elderly
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of oral intake of flaxseed oil which is rich in alpha-linolenic acid, and classified as the omega-3 fatty acids on cognitive function of healthy subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Before and after 6 and 12 weeks of Flaxseed oil consumption cognitive function will be evaluated.
Key secondary outcomes
Before and after 6 and 12 weeks of flaxseed oil consumption, the following items will be evaluated:
Food frequency
Depression
QOL
Physical conditions
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants in flaxseed oil group are asked to take a flaxseed oil containing package with no prints.
Flaxseed oil 3.7g/package, 1package/day for 12 weeks.
Interventions/Control_2
Corn oil is used as placebo. Corn oil containing package with no prints is used.
corn oil 3.7g/package,1package/day for 12 weeks.
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Mini Mental State Examination (MMSE) more than 27points
2.Clinical Dementia Rating (CDR) 0point
3.65-80 years old when admitted
4.Right handed
5.Signed informed consent
Key exclusion criteria
1.Severe past history of brain, psychological and internal disease
2.Severe visual and hearing disturbance
3.Excessive slimming/obesity (BMI less than 17, more than 30)
4.History of long term flaxseed oil consumption
5.Frequent fish intake
6.Mental illness or psychiatric symptoms and are judged to be difficult to participate in the study by physician
7.Any participant who is judged not suitable for this study by physician
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Kawashima |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
9808575
Address
4-1 Seiryocho, Aobaku, Sendai, Miyagi
TEL
022-717-7988
ryuta.kawashima.a6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Toshimi |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer
Zip code
9808575
Address
4-1 Seiryocho, Aobaku, Sendai, Miyagi
TEL
022-717-7988
Homepage URL
toshimi.ogawa.e6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
NIPPON FLOUR MILLS Co.,Ltd
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryocho, Aobaku, Sendai, Miyagi
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 24 | 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
60
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
| 2020 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 22 | Day |
Last modified on
| 2022 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045507
