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
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
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
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
