UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050219 |
|---|---|
| Receipt number | R000057188 |
| Scientific Title | Confirmatory study of the efficacy and effectiveness of egg consumption on cognitive function improvement in Japanese adults - A placebo-controlled, double-blind, randomized, comparative trial-. |
| Date of disclosure of the study information | 2023/02/07 |
| Last modified on | 2024/05/21 14:13:27 |
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Basic information
Public title
Confirmatory study of the efficacy and effectiveness of egg consumption on cognitive function improvement in Japanese adults - A placebo-controlled, double-blind, randomized, comparative trial-.
Acronym
Confirmatory study of the efficacy and effectiveness of egg consumption on cognitive function improvement in Japanese adults.
Scientific Title
Confirmatory study of the efficacy and effectiveness of egg consumption on cognitive function improvement in Japanese adults - A placebo-controlled, double-blind, randomized, comparative trial-.
Scientific Title:Acronym
Confirmatory study of the efficacy and effectiveness of egg consumption on cognitive function improvement in Japanese adults.
Region
| Japan |
Condition
Condition
Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy and effectiveness of 12 weeks of dietary supplementation on cognitive function in adults with subjective or objective cognitive decline aged 55 years or older and less than 80 years.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax basic: Composite Memory
Key secondary outcomes
Cognitrax basic: Verbal Memory, Visual Memory, Psychomotor Speed, Response Time, Complex Attention, Cognitive Flexibility, Process Speed, Executive Function, Simple Attention, and Motor Speed.
Trail Making Test Japanese Version (TMT-J)
Other outcomes: miRNA measurement, BDHQL
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 a piece of the test diet twice a day, one after breakfast and the other between lunch and dinner.
Interventions/Control_2
Take a piece of the control diet twice a day, one after breakfast and the other between lunch and dinner.
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 male or female aged 55 years or older and less than 80 years at the time of consent.
2. Have a sense of forgetfulness or receive an objective suggestion.
3. MMSE-J score equal to or above 24 at the SCR.
4. Every validity indicator for the Cognitrax score, including Composite Memory, Verbal Memory, and Visual Memory, is "yes".
5. Has a relatively low Composite Memory score on the Cognitrax test.
6. Can write an electronic daily log using smartphones or PCs.
7. Received an adequate explanation of the purpose of the study and voluntarily participated in the study under informed consent.
Key exclusion criteria
1. Taking foods or dietary supplements with functional health claims that may affect the outcome of the study, such as FOSHU, and FFC, more than three times per week and are unable to discontinue taking these foods after the time of consent.
2. Are regularly taking medications that may affect the outcome of the study, such as antibiotics, bowel preparations, laxatives, and medications for psychiatric disorders, and are unable to limit the use of these medications after the time of consent.
3. Are diagnosed with lipidemia, and receive treatment.
4. Are diagnosed with dementia, and receive treatment.
5. Heavy drinker, greater than or equal to 60 grams of alcohol per day.
6. Have irregular eating habits or rhythm of daily life.
7. Have intense regular exercise habits.
8. Voluntarily take bluefish such as sardines, mackerel, and saury.
9. Have an egg intake amount greater than or equal to 14 per week in daily life.
10. Daily use of brain-training materials that may affect cognitive function, such as devices, digital applications, or games.
11. Serious heart, liver, renal, or gastrointestinal disease or a history of such disease.
12. Allergies to any medications or foods.
13. Are currently participating in other clinical trials, plan to participate in other clinical trials three months after the end of the study, plan to participate in other clinical trials after consenting to the study, and experienced the Cognitrax six months before consenting to the study.
14. Have donated more than 200 mL of blood within one month before the start of the study.
15. Have a blood donation volume greater than 1200 mL, which is the sum of the planned blood donation volume in the study and the previous blood donation volume within 12 months before the start of the study.
16. Unsuitable for the study, as determined by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
HigashiKoganei Sakura Clinic
Division name
Director
Zip code
184-0011
Address
4-37-26, Higashicho, Koganei-shi, Tokyo, 184-0011, Japan
TEL
042-382-3888
clinical-trial@imeqrd.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
Daiwa Ginza Bld. 3F, 6-2-1, Ginza, Chuo-ku, Tokyo, 104-0061, Japan
TEL
0367045968
Homepage URL
https://imeqrd.co.jp/
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Research program on development of innovative technology, Bio-oriented Technology Research Advancement Institution, NARO, MAFF
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The University of Tokyo
Kewpie Corporation
Tokyo Medical University School Of Medicine Alumni Association
Kanagawa Institute of Industrial Science and Technology
CPCC Company Limited
Name of secondary funder(s)
Kewpie Corporation
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
0367045968
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
| 2023 | Year | 02 | Month | 07 | 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 | 01 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 07 | 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 | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057188
