UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045684 |
|---|---|
| Receipt number | R000052035 |
| Scientific Title | An interventional study for verifying recognition-improving effects by ingesting a whole egg |
| Date of disclosure of the study information | 2021/10/10 |
| Last modified on | 2023/03/14 10:43:37 |
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Basic information
Public title
An interventional study for verifying recognition-improving effects by ingesting a whole egg
Acronym
An interventional study for verifying recognition-improving effects by ingesting a whole egg
Scientific Title
An interventional study for verifying recognition-improving effects by ingesting a whole egg
Scientific Title:Acronym
An interventional study for verifying recognition-improving effects by ingesting a whole egg
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate some kind of recognition-improving effect by ingesting the test-food to the volunteers for twelve weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitrax basic ver. (Verbal Memory, Visual Memory, Finger Tapping, Symbol Digit Coding, Stroop Test, Shifting Attention, Continuous Performance)
Key secondary outcomes
Japanese version of the trail making test
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
Ingestion of the test-food to the volunteers one a day for twelve weeks.
Interventions/Control_2
Ingestion of the placebo-food to the volunteers one a day for twelve 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) Male/female Japanese volunteers ranging in age from 55 to 79.
(2) Volunteers fully realized that the volunteers themselves must be in forgetfulness, or have been pointed out such tendency.
(3) Volunteers having a MMSE-J score of not less than twenty-six.
(4) Volunteers who can give informed consent to take part in this research, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Volunteers who take steadily (not less than three times a week) in the health-specific/functional/supplementary/health foods, which might affect the test results.
(2) Volunteers who have taken affecting medicines (e.g., antibiotic/gut/laxative regulation), and have any difficulty in refraining from taking them during this study.
(3) Volunteers being under medical treatment for dyslipidemia, after diagnosis.
(4) Volunteers being under medical treatment for dementia, after diagnosis.
(5) Volunteers who take excessive alcohol.
(6) Volunteers having extremely irregular eating habits, and irregular life rhythms.
(7) Volunteers who have a habit of daily vigorous exercises.
(8) Volunteers who take not less than fourteen eggs in their daily life.
(9) Volunteers who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases.
(10) Pregnant, possibly pregnant, and lactating women.
(11) Volunteers having drug and/or food allergy (especially to egg and wheat).
(12) Volunteers who are now under another clinical test with some kind of medicine and/or health food, or took part in that within four weeks before this study, or will participate in that after giving informed consent to take part in this study.
(13) Volunteers who donated their blood components and/or whole blood (200 mL) within a month to this trial.
(14) Volunteers who donated their whole blood (400 mL) within the last three months to this trial.
(15) Volunteers who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this study.
(16) Others who have been determined as ineligible for participation, according to the principal investigator's opinion.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shukuko |
| Middle name | |
| Last name | Ebihara |
Organization
Chiyoda Paramedical Care Clinic
Division name
Director
Zip code
101-0047
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-5548
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
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo
Kewpie Corporation
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
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
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
| 2021 | Year | 10 | Month | 10 | 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
| 2021 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 11 | 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 | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052035
