UMIN-CTR Clinical Trial

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
Email	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
Email	toshimi.ogawa.e6@tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045507