UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046397 |
|---|---|
| Receipt number | R000052941 |
| Scientific Title | A dose finding study on the effect of continuous intake of test foods on the cognitive function. -a randomized, double-blind, parallel-group comparison trial- |
| Date of disclosure of the study information | 2021/12/19 |
| Last modified on | 2024/05/16 15:58:38 |
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Basic information
Public title
A dose finding study on the effect of continuous intake of test foods on the cognitive function.
-a randomized, double-blind, parallel-group comparison trial-
Acronym
A dose finding study on the effect of continuous intake of test foods on the cognitive function.
-a randomized, double-blind, parallel-group comparison trial-
Scientific Title
A dose finding study on the effect of continuous intake of test foods on the cognitive function.
-a randomized, double-blind, parallel-group comparison trial-
Scientific Title:Acronym
A dose finding study on the effect of continuous intake of test foods on the cognitive function.
-a randomized, double-blind, parallel-group comparison trial-
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the dose dependent effect of continuous intake of test foods for 12 weeks on cognitive function in healthy males and females aged between 65 and less than 80 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function test (eye-tracking test)
Key secondary outcomes
Cognitive function test (MMSE-J), QOL questionnaire
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take six tablets of the test food (high dose) after breakfast once every day for 12 weeks
Interventions/Control_2
Take six tablets of the test food (low dose) after breakfast once every day for 12 weeks
Interventions/Control_3
Take six tablets of the placebo food after breakfast once every day for 12 weeks
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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged between 65 and less than 80 years old.
2. Japanese males and females.
3. Those who have subjective symptoms of cognitive decline and are judged by the investigators to have no problem participating in the study.
4. Those who were not pointed out high blood pressure at medical checkup.
5. Those who can input their own data into the electronic diary.
6. Those who received sufficient explanation for the objective and summary of the trial, and voluntarily volunteered to the trial with the agreement of informed consent.
Key exclusion criteria
1. Those who are receiving any types of medicines and/or Chinese medical treatment.
2. Those who are managed by medical doctors for diet/exercise therapy.
3. Those who have severe diseases or a history of severe diseases.
4. Those who have strabismus, cataracta, or have surgical history of eye within 1year ago from the date of consent.
5. Those who have currently been taking commercially available drugs, quasi-drug products, and foods or supplements with functional claims.
6. Those who have a drug/food allergy.
7. Those whose MMSE-J score are less than 24, or over 29.
8. Those who drink more than 60 g alcohol/day.
9. Those who have excessive smoking habits (21 or more cigarettes / day)
10. Those who are planning extremely change their lifestyle during the trial.
11. Those who are planning travel to foreign countries during the trial.
12. Those who joined other clinical trials from 1 month before this trial, or those who have currently been joined or planning to join other clinical trials.
13. Those who are unsuitable for this trial, that judged by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshie |
| Middle name | |
| Last name | Tokuta |
Organization
JELLICE CO., LTD.
Division name
Production & Development group Technical center
Zip code
985-0833
Address
4-4-1 Sakae Tagajo-city Miyagi
TEL
022-361-8821
y.tokuta@jellice.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
JELLICE 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2021 | Year | 12 | Month | 19 | 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
60
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
| 2021 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052941
