UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041980
Receipt number R000047915
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
Date of disclosure of the study information 2021/12/27
Last modified on 2021/03/31 15:19:41

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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 or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047915