UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052060 |
|---|---|
| Receipt number | R000059402 |
| Scientific Title | A clinical study for evaluating the effects of intake of test food on cognitive function: A randomized, double-blind, placebo-controlled, parallel-group comparative method |
| Date of disclosure of the study information | 2023/08/30 |
| Last modified on | 2025/02/28 10:42:39 |
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Basic information
Public title
A clinical study for evaluating the effects of intake of test food on cognitive function: A randomized, double-blind, placebo-controlled, parallel-group comparative method
Acronym
A clinical study for evaluating the effects of intake of test food on cognitive function
Scientific Title
A clinical study for evaluating the effects of intake of test food on cognitive function: A randomized, double-blind, placebo-controlled, parallel-group comparative method
Scientific Title:Acronym
A clinical study for evaluating the effects of intake of test food on cognitive function
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of lactic acid bacteria-containing food on cognitive function after 12 weeks of continuous intake, using a placebo as a control
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function tests
Key secondary outcomes
Blood biomarkers (antioxidant, inflammation, glucose metabolism, lipid metabolism)
Subjective psychological assessments
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
Continuous intake of test food for 12 weeks
Interventions/Control_2
Continuous intake of placebo 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
| 60 | years-old | <= |
Age-upper limit
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 60 to 74 years old
(2) Subjects who are concerned about cognitive functions such as forgetfulness
(3) Subjects with an MMSE score of >=24 and <=29
(4) Subjects who understand sufficiently the purpose and content of this study and voluntarily agree to participate in this study
Key exclusion criteria
Subjects
(1) with an MMSE score of <=23
(2) who have difficulty distinguishing colors and performing cognitive tests
(3) with poor eyesight
(4) with poor hearing
(5) who have difficulty operating a computer
(6) who cannot answer online survey
(7) who have or have a history of dementia, mental disease, etc. or who are suspected
(8) who have or have a history of drug or alcohol dependence
(9) who have a menopausal disorder
(10) who have or have a history of serious illness
(11) who take medicines that may affect the research
(12) who may develop allergies
(13) who continuously take health foods that may affect cognitive function
(14) who continuously take health foods that may affect blood biomarkers and cannot stop during the study
(15) who continuously take foods containing a lot of lactic acid bacteria, etc. or medicines that may affect the intestinal environment
(16) who are lactose intolerant or prone to diarrhea caused by dairy products
(17) who are prone to diarrhea due to alcohol intake
(18) who have diarrhea frequently
(19) who have irregular lifestyle habits multiple times during the study
(20) who plan to change their lifestyle during the study
(21) who smoke more than 21 /day
(22) who regularly take too much alcohol
(23) who have participated in other study within a month before the consent or who plan to participate in other study during the study
(24) who have taken a cognitive test conducted in this study within 3 months before the test, or who plan to take a cognitive test during the study
(25) who donated or received blood transfusion within 3 months before the screening test, or donated blood components within 2 weeks before the test
(26) who are judged to be unsuitable from the lifestyle questionnaire
(27) who are judged to be unsuitable based on the results of clinical or physical examination
(28) who are judged to be unsuitable by doctor for other reasons
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shunjiro |
| Middle name | |
| Last name | Kobayashi |
Organization
MEGMILK SNOW BRAND Co., Ltd.
Division name
Milk Science Research Institute
Zip code
350-1165
Address
1-1-2 Minamidai, Kawagoe, Saitama 350-1165, Japan
TEL
049-242-8060
syunjirou-kobayashi@meg-snow.com
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Kondo |
Organization
EP Mediate Co., Ltd.
Division name
Foods Department, Trial Planning Section 2
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8, Tsukudo-cho, Shinjuku-ku, Tokyo
TEL
070-3023-8211
Homepage URL
kondo.mariko793@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MEGMILK SNOW BRAND 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.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 | 08 | 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
150
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 | 10 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059402
