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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name