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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031250
Receipt No. R000035681
Official scientific title of the study The evaluation test of cognitive function by oral consumption of the food which contain plasmalogen
Date of disclosure of the study information 2018/08/11
Last modified on 2018/05/01

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Basic information
Official scientific title of the study The evaluation test of cognitive function by oral consumption of the food which contain plasmalogen
Title of the study (Brief title) The evaluation test of cognitive function by oral consumption of the food which contain plasmalogen
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the improving effect of cognitive function and the change of the concentration of plasmalogen, amyloid beta and BDNF in blood, by 12 weeks consumption of test foods.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Basical 7 tests of the Cognitrax
Plasmalogen
Amyloid beta
BDNF
Key secondary outcomes High sensitive CRP in blood
8-OHdG in urine
The incidence of side effects and adverse events.

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 Treatment
Type of intervention
Food
Interventions/Control_1 Intake 2 capsules those contain test food 1 after dinner, for 12 weeks.
Interventions/Control_2 Intake 2 capsules those contain test food 2 after dinner, for 12 weeks.
Interventions/Control_3 Intake 2 capsules those contain no test food after dinner, 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
50 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Males and females aged 50 to 79 when informed consent.
2) Subjects who aware that their memory ability reduced compare to own younger age.
3) Subjects giving written informed consent.
Key exclusion criteria 1) Subjects who constantly use oral medicines, functional foods and/or supplements having a possibility of affecting test results.
2) Subjects who have previous and/or current medical history of serious disease such as cerebral infarction, cerebrovascular disease, psychosis, dementia and so on.
3) Subjects who are given continuous treatment by taking medicines.
4) Subjects who excessive alcohol intake.
5) Subjects who's MMSE-J scores are under 26 points.
6) Subjects who have already been done neuropsychological test at clinic.
7) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
8) Subjects who have previous medical history of drug and/or food allergy.
9) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
10) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
11) Males who donated over 400mL blood and/or blood components within the last three month to the current study.
12) Females who donated over 400mL blood and/or blood components within the last four month to the current study.
13) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
14) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
15) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size 75

Research contact person
Name of lead principal investigator Satoshi Kotoura
Organization MARUDAI FOOD CO.,LTD.
Division name CENTRAL RESEARCH INSTITUTE
Address 21-3, Midori-Cho, Takatsuki-Shi, Osaka, 569-8577,JAPAN
TEL 072-661-2552
Email kotoura_satoshi@marudai.co.jp

Public contact
Name of contact person Kazuyoshi Shibata
Organization CPCC Company Limited
Division name Planning & Sales Department
Address 4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-5927-3112
Homepage URL
Email cpcc-contact@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

Funding Source
Organization MARUDAI FOODS CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 08 Month 11 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 01 Month 18 Day
Anticipated trial start date
2018 Year 03 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 02 Month 11 Day
Last modified on
2018 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035681

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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