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 |
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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
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/
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
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
