UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055300 |
|---|---|
| Receipt number | R000063190 |
| Scientific Title | Preliminary study to confirm the effect of test food intake on cognitive function |
| Date of disclosure of the study information | 2024/08/24 |
| Last modified on | 2024/12/24 14:44:29 |
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Basic information
Public title
Preliminary study to confirm the effect of test food intake on cognitive function
Acronym
Preliminary study to confirm the effect of test food intake on cognitive function
Scientific Title
Preliminary study to confirm the effect of test food intake on cognitive function
Scientific Title:Acronym
Preliminary study to confirm the effect of test food intake on cognitive function
Region
| Japan |
Condition
Condition
Healty volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A pilot study to confirm the effects of two test foods with different composition ratios on cognitive function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function test (Cognitrax: Basic)
Key secondary outcomes
Defecation status (frequency of bowel movements, amount of stool, shape of stool, feeling of incomplete bowel movement, abdominal pain during defecation, odor)
Blood biochemistry test, hematology test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food A for 12 weeks.
Interventions/Control_2
Ingestion of test food B 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)Japanese males and females who are between 55 and 80 years of age.
2) People who are aware that they forget things, or who have been told by others that they forget things
3)People who are not receiving treatment for an illness.
4)Those who understand the contents of the clinical trial, wish to participate in the trial, and can provide written consent.
5)Those who can maintain a consistent daily lifestyle during the clinical trial
Key exclusion criteria
1) Those who have been taking medicines regularly within 3 months prior to the start of the clinical trial (excluding temporary medications such as painkillers and cold medicines).
2) Are diagnosed with serious illness (diabetes, heart disease, liver disease, kidney disease, cancer, etc.) or mental illness.
3) Have a history of serious illness. (diabetes, heart disease, liver disease, kidney disease, cancer, etc.)
4) Those who have been using foods for specified health uses, foods with functional claims, or supplements more than three times a week within the three months prior to the start of the study that may affect the clinical trial.
5) Those who are unable to stop taking foods for specified health uses, foods with functional claims, or supplements during the clinical trial period, which may affect the clinical trial.
6) Those who have been diagnosed with dementia or are undergoing treatment for dementia.
7) Those who drink a lot of alcohol (40g or more of pure alcohol per day on average).
8) Those with extremely irregular eating habits or those who work night shifts or have other irregular lifestyles.
9) Allergies to any medications or test foods.
10) Those who participated in clinical trials of cognitive or brain function within 6 months of the start of this clinical trial.
11) Those who are currently participating in a clinical trial of another drug or health food, have completed the trial within 4 weeks, or plan to participate in another clinical trial while participating in this trial.
12) Others who have been determined ineligible by principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watanabe |
Organization
Watanabe Hospital
Division name
chairperson
Zip code
144-0043
Address
1-5-16, Haneda, Ota-ku, Tokyo, Japan
TEL
03-3741-0223
wnb.cto@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuo |
| Middle name | |
| Last name | Uetake |
Organization
CXwellness, Inc.
Division name
Representative Directo
Zip code
173-0004
Address
2-63-9-401 Itabashi, Itabashi-ku, Tokyo JAPAN
TEL
03-6915-5507
Homepage URL
uetake@cx-wellness.com
Sponsor or person
Institute
Nikorio Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nikorio Co., Ltd.
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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
wnb@cto-net.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
| 2024 | Year | 08 | Month | 24 | 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
20
Results
Significant increases in neurocognitive indices were observed in the Food A intake group and the Food B intake group. Additionally, a significant increase in overall memory was observed in the Food A intake group, and a near-significant increase in verbal memory was observed in the Food A intake group and the Food B intake group.
Results date posted
| 2024 | Year | 12 | Month | 24 | Day |
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
| 2024 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 21 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063190
