UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052112 |
|---|---|
| Receipt number | R000059478 |
| Scientific Title | Research on improving brain function through food intake. |
| Date of disclosure of the study information | 2023/09/30 |
| Last modified on | 2024/08/05 11:20:25 |
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Basic information
Public title
Research on improving brain function through food intake.
Acronym
Research on improving brain function through food intake.
Scientific Title
Research on improving brain function through food intake.
Scientific Title:Acronym
Research on improving brain function through food intake.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of the test food, PQQ-containing foods, on brain function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comprehensive memory score by Cognitrax.
Key secondary outcomes
Scores in each study using Cognitrax.
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
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Foods containing PQQ
Interventions/Control_2
Foods not containing PQQ.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Men and women aged between 18 and 65 years
(2) Persons with a BMI of less than 30 kg/m2
(3) Persons who give written voluntary consent to participate in the study
Key exclusion criteria
(1) Persons without serious cardiac, cerebral or endocrine disease.
(2) Those with head injuries
(3) Who are currently on medication for any disease
(4) Persons with a history of drug allergy or serious food allergy
(5) Persons who regularly use medicines, quasi-drugs or psychiatric drugs
(6) Persons who have been judged by the investigator to be unsuitable as subjects
(7) Persons who are currently receiving medication for any disease
(8) Persons who are judged by the study investigator (or the study manager) to be unsuitable to participate in the study.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Ryuji |
| Middle name | |
| Last name | Takeda |
Organization
Kansai University of Welfare Sciences
Division name
Department of Nutritional Sciences for Welll-being, Faculty of Health Science for Welfare
Zip code
582-0026
Address
Asahigaoka 3-11-, Kashiwara-city, Osaka, Japan
TEL
0729780088
rtakeda@tamateyama.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Fukumoto |
Organization
CTSC Inc.
Division name
Clinical Trial Session
Zip code
170-0013
Address
Halleza Tower, 19th Floor, 1-18-1 Higashi-Ikebukuro, Toshima-ku, Tokyo
TEL
170-8422
Homepage URL
info@eas-ct.jp
Sponsor or person
Institute
EAS Inc
Institute
Department
Personal name
Funding Source
Organization
EAS Inc.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KOBUNA ORTHOPEDIC SURGERY
Address
311-2, Gokan-machi, Maebashi, Gunma
Tel
027-212-5608
sagawa@mc-connect.co.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
| 2023 | Year | 09 | Month | 30 | 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
| 2023 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059478
