UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050239 |
|---|---|
| Receipt number | R000051969 |
| Scientific Title | Evaluation of the effect of polyphenol (hydroxytyrosol) intake on cognitive function in middle-aged and elderly people |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/08/16 13:16:22 |
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Basic information
Public title
Evaluation of the effect of polyphenol (hydroxytyrosol) intake on cognitive function in middle-aged and elderly people
Acronym
Evaluation of the effect of hydroxytyrosol intake on cognitive function
Scientific Title
Evaluation of the effect of polyphenol (hydroxytyrosol) intake on cognitive function in middle-aged and elderly people
Scientific Title:Acronym
Evaluation of the effect of hydroxytyrosol intake on cognitive function
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify the effect of ingesting olive extract containing a large amount of hydroxytyrosol component, the following is carried out.
1. Amyloid beta, BDNF, and oxidative stress will be measured as the primary endpoints of cognitive function in RCTs (80 subjects, 2 groups: polyphenol intake group, placebo group, duration 12 weeks).
2. Physical function is measured as a secondary endpoint.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitrax test
Key secondary outcomes
Blood concentrate of amyloid beta 1-40
Blood concentrate of amyloid beta 1-42
Brain-derived neurotrophic factor
Trail making peg test
Geriatric Depression Scale
Pittsburgh Sleep Quality Index
JKOM
Physical Activity Scale for the Elderly
J-CHS
Grip strength
One-leg balance with eyes open test
Timed up and go test
5-m walk test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Pearls rich in Hydroxytyrosol group
Interventions/Control_2
Olive oil group
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) Middle-aged and elderly people
2) A person who can go to the place where the experiment is conducted on their own.
Key exclusion criteria
1)A person with paralysis
2)A person who has an allergic reaction to the ingredients of the test food
3)A person who is currently participating in other clinical studies or who have participated within 3 months.
4)A person who is judged by the principal investigator to be inappropriate as the subjects of this study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tomohir |
| Middle name | |
| Last name | Okura |
Organization
University of Tsukuba
Division name
Faculty of Health and sport science
Zip code
305-8574
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
+81-29-853-2733
okura.tomohiro.gp@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Jieun |
| Middle name | |
| Last name | YOON |
Organization
University of Tsukuba
Division name
R&D Center for Tailor-Made QOL
Zip code
305-8550
Address
1-2, kasuga, Tsukuba, Ibaraki, Japan
TEL
+81-29-859-1593
Homepage URL
yoon.jieunfu@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
MED R&D
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
University of Tsukuba, Faculty of Health and sport science, Research Ethics Committee
Address
1-1-1, Tenodai, Tsukuba, Ibaraki
Tel
+81-029-853-2571
tg-kenkyurinri@un.tsukuba.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
筑波大学
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.mdpi.com/2072-6643/15/14/3234
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2072-6643/15/14/3234
Number of participants that the trial has enrolled
72
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
| 2021 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 10 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 05 | Day |
Last modified on
| 2023 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051969
