UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the effects of vegetable oil intake on immunity and mental and physical QOL
Acronym	Examination of the effects of vegetable oil intake on immunity and mental and physical QOL
Scientific Title	Examination of the effects of vegetable oil intake on immunity and mental and physical QOL (motivation, cognition, etc.) for healthy adult men and women who are worried about mental and physical deterioration due to aging
Scientific Title:Acronym	Examination of the effects of vegetable oil intake on immunity and mental and physical QOL (motivation, cognition, etc.) for healthy adult men and women who are worried about mental and physical deterioration due to aging
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of vegetable oil intake for 8 consecutive weeks on immunity and mental and physical QOL using placebo as a control
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PASAT and Stroop before and after 8 weeks
Key secondary outcomes	s-IgA and SF-36 before and after 8 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingest vegetable oil for 8 consecutive weeks
Interventions/Control_2	Ingest placebo for 8 consecutive 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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females from 40 years of age (2) Subjects who are aware of the deterioration of memory due to aging (3) Subjects with inferior scores of primary outcome (4) Subjects with inferior score on the questionnaire
Key exclusion criteria	(1) Subjects who regularly use health foods, etc. that contain many ingredients that may affect research results (2) Subjects who have symptoms that affect the performance of the test (3) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (4) Subjects who have been diagnosed as menopausal symptoms (5) Subjects who have depressive symptoms, or who have been diagnosed as depressive disorder (6) Subjects who take medications that may affect research results (7) Subjects who have diseases requiring regular administration, or who have severe diseases (8) Subjects who sometimes have irregular lifestyles during the study (9) Smokers or subjects who started smoking cessation within 12 months (10) Subjects who have performed the same tests as the primary endpoint of this study within 12 months (11) Subjects who have done blood transfusion or blood donation within 3 months (12) Subjects who have participated in other clinical studies within 1 month, or who are planning to participate in other clinical studies during this study (13) Subjects who are, or are planning to be pregnant or breastfeeding during study (14) Subjects who are judged as unsuitable by doctor for laboratory value, anthropometric measurements, or physical examination value (15) Subjects who are at risk of developing allergies related to research (16) Subjects who are judged as unsuitable due to lifestyle questionnaire (17) Subjects who are judged as unsuitable by doctor for other reasons
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Sumio Middle name Last name Kondo
Organization	Medical Corporation Kensho-kai, Fukushima Healthcare Center
Division name	Internal Medicine, Department of Neurosurgery
Zip code	553-0004
Address	2-12-16 Tamagawa, Fukushima-ku, Osaka-shi, Osaka
TEL	06-6882-1130
Email	s.kondo@drc-web.co.jp

Public contact
Name of contact person	1st name Kotoha Middle name Last name Isobe
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.isobe@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	non-disclosure
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	t.saito@ttc-smo.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	2021 Year 12 Month 27 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	2020 Year 09 Month 24 Day
Date of IRB	2020 Year 09 Month 24 Day
Anticipated trial start date	2020 Year 10 Month 05 Day
Last follow-up date	2020 Year 12 Month 27 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 10 Month 02 Day
Last modified on	2021 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047915