UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041006
Receipt number R000046825
Scientific Title Effects of dietary supplement containing peanuts components on cognitive functions in healthy Japanese adults: A randomized double-blind placebo-controlled trial-blind placebo-controlled trial
Date of disclosure of the study information 2021/08/08
Last modified on 2023/10/16 14:38:01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of dietary supplement containing peanuts components on cognitive functions in healthy Japanese adults

Acronym

Effects of dietary supplement containing peanuts components on cognitive functions in healthy Japanese adults

Scientific Title

Effects of dietary supplement containing peanuts components on cognitive functions in healthy Japanese adults: A randomized double-blind placebo-controlled trial-blind placebo-controlled trial

Scientific Title:Acronym

Effects of dietary supplement containing peanuts components on cognitive functions in healthy Japanese adults

Region

Japan


Condition

Condition

Healthy Japanese adults aged 60 and over

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects of taking the dietary supplement containing peanuts components on cognitive functions in healthy adults aged 60 and over.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1.The measured values of Benton Visual Retention Test at right before and after 4 weeks to take the dietary supplements
2.The measured values of Standard verbal paired-associate learning test at right before and after 4 weeks to take the dietary supplements

Key secondary outcomes

The measured values of Mini-Mental State Examination(MMSE) at right before and after 4 weeks to take the dietary supplements


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

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

To take 15 dietary supplements containing peanuts components per day for 4 weeks

Interventions/Control_2

To take 15 placebo per day for 4 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

60 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

(1)Persons who are generally judged
as a healthy person and his age is between 60 years-old and 85 years-old
(2)Persons who can give voluntary written consent to participate in the present trial

Key exclusion criteria

(1) Persons who are on night duty or have the day and the night shift.
(2)Persons who have been treated their illness such as hormone replacement therapy and drug/exercise/diet therapy, or judged as a condition needs to be treated at medical institute.
(3)Persons with their medical histories as follows: serious diseases of glyco metabolism, lipid metabolism, hepatic function, renal function, heart, circulatory organ, respiratory organs, endocrine system, immune system, nervous system or mental illness
(4)Persons with the medical histories of alcoholism or drug dependence
(5)Persons who might be developed allergic reaction to foods.
(6)Persons who are pregnant, at the lactation period or wish to get pregnant during this trial period.
(7)Persons who had participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device for humans)
(8)Persons who judged as non-suitable participants in the present trial by the investigator.

Target sample size

37


Research contact person

Name of lead principal investigator

1st name Kuniyoshi
Middle name
Last name Shimizu

Organization

Kyushu University

Division name

Graduate School of Bioresource and Bioenvironmental Sciences

Zip code

819-0395

Address

744, Motooka, Nishi-ku, Fukuoka 819-0395, Japan

TEL

092-802-4675

Email

shimizu@agr.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Kuniyoshi
Middle name
Last name Shimizu

Organization

Kyushu University

Division name

Graduate School of Bioresource and Bioenvironmental Sciences

Zip code

819-0395

Address

744, Motooka, Nishi-ku, Fukuoka 819-0395, Japan

TEL

092-802-4675

Homepage URL

https://userlife.science/clinical/recruit/cognition-recruit/

Email

shimizu@agr.kyushu-u.ac.jp


Sponsor or person

Institute

Graduate School of Bioresource and Bioenvironmental Sciences in Kyushu University

Institute

Department

Personal name



Funding Source

Organization

MITSUYA CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Faculty of humanity-oriented science and engineering in Kindai University

Name of secondary funder(s)



IRB Contact (For public release)

Organization

The ethical committee of Kindai University, Faculty of humanity-oriented science and engineering

Address

11-6, Kayanomori, Iizuka-shi, Fukuoka, Japan

Tel

0948-22-5655

Email

ohnuki@fuk.kindai.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

九州大学 病院キャンパス コラボステーションⅡ 412室・711室


Other administrative information

Date of disclosure of the study information

2021 Year 08 Month 08 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

37

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 06 Month 22 Day

Date of IRB

2020 Year 03 Month 01 Day

Anticipated trial start date

2020 Year 07 Month 06 Day

Last follow-up date

2020 Year 08 Month 09 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 07 Month 05 Day

Last modified on

2023 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046825


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name