UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057405 |
|---|---|
| Receipt number | R000065589 |
| Scientific Title | Investigation of the effects by ingesting the test food on cognitive function and bowel movements |
| Date of disclosure of the study information | 2025/03/30 |
| Last modified on | 2025/09/24 09:28:47 |
* 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
Investigation of the effects by ingesting the test food on cognitive function and bowel movements
Acronym
Investigation of the effects by ingesting the test food on cognitive function and bowel movements
Scientific Title
Investigation of the effects by ingesting the test food on cognitive function and bowel movements
Scientific Title:Acronym
Investigation of the effects by ingesting the test food on cognitive function and bowel movements
Region
| Japan |
Condition
Condition
Males and females aged 55 to 80 years old
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of ingesting the test food on cognitive function and bowel movements
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function (Cognitrax Basic)
Key secondary outcomes
Efficacy evaluation item
BDNF in blood
Self-report dementia checklist
The Profile of Mood States Second Edition(Japanese short ver.)
Defecation status(frequency, the number of days, quantity, property, feeling of incomplete evacuation, abdominal pain, fecal odor)
Physical measurements(weight, BMI)
Blood biochemistry test
Safety evaluation items
Adverse events and side effects
Physiological tests
Hematological tests
General urine tests
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take one capsule of the test food per day with water or lukewarm water for 12 weeks.
Interventions/Control_2
Take one capsule of the control food per day with water or lukewarm water for 12 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
| 55 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Males and females aged 55 to 80 years old at the time of consent.
(2) Subjects who are aware of forgetfulness or have been told they have forgetfulness.
(3) Subjects whose MMSE-J score of 24 or higher before the pre-test and intake.
(4) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects who are having Food for Specified Health Uses (FOSHU), Foods with functional claims and/or health foods, including supplements, etc. at least three times a week for three months prior to the date of consent, which may affect this study.
(2) Subjects who are unable to stop ingesting foods for Specified Health Uses (FOSHU), Foods with functional claims and/or health foods, including supplements, etc. that may affect this study from the time of obtaining consent
(3) Subjects who are taking medicines that may affect the study (dementia medication, antibiotics, laxatives, intestinal regulators, etc.) and cannot limit their intake during the study period.
(4) Subjects who have been diagnosed with dementia and are receiving treatment.
(5) Subjects who have extremely irregular eating habits or lifestyles.
(6) Subjects who are participating, participated within the last four weeks before this study, or are planning to participate another clinical study of medication or health food.
(7) Heavy drinkers.
(8) Subjects who are aware that they have color vision deficiency (including those who have been diagnosed with color vision deficiency in the past).
(9) Subjects who have past and present medical history of serious diseases of brain, heart, liver, kidney, digestive organs, and/or thyroid gland, etc.
(10) Subjects who are allergic to drugs or foods (especially salmon).
(11)-(15) Subjects who have donated a lot of whole blood and/or blood components within the last 12 months prior to this study.
(16) Subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numa |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Nicorio Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nicorio Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
IRB@cpcc.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
| 2025 | Year | 03 | 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
| 2025 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065589
