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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000045684
Receipt No. 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 2021/10/06

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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
Email 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
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

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
Email 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 Preinitiation
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
2021 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052035

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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