UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024751
Receipt No. R000028474
Scientific Title Examination of brain function improvement of plasmalogen intake.
Date of disclosure of the study information 2016/11/08
Last modified on 2017/05/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Examination of brain function improvement of plasmalogen intake.
Acronym The effect of plasmalogen on cognitive functions.
Scientific Title Examination of brain function improvement of plasmalogen intake.
Scientific Title:Acronym The effect of plasmalogen on cognitive functions.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 n order to examine the brain function improvement of plasmalogen intake, we conduct placebo-controlled double-blind comparative study and evaluate measurement of blood pressure and pulse, blood test, RBANS test, physical measurement, Cognitrax(measurement of cognitive function).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 3 month later , evaluation of cognitive functions by RBANS and Cognitrax
Key secondary outcomes Measurement of blood pressure and pulse, Blood test,Physical measurement

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 4
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 High dose:8 capsules once a day :Take the capsules with water after meals in the evening. 12 weeks.
Interventions/Control_2 Middle dose:8 capsules once a day :Take the capsules with water after meals in the evening. 12 weeks.
Interventions/Control_3 Low dose:8 capsules once a day :Take the capsules with water after meals in the evening. 12 weeks.
Interventions/Control_4 Placebo:8 capsules once a day :Take the capsules with water after meals in the evening. 12 weeks.
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1 Japanese male and female at the age of 50 to 79 at first observation including screening.
2 A person who feels more forgetful than early life.
Key exclusion criteria 1 A person who possibly shows food allergy symptom.
2 A person who had been treated, hospitalized or operated for stroke, subarachnoid hemorrhage, cerebral infarction, cerebral haemorrhage, brain contusion or head trauma.
3 A person who is alcohol or nicotine addict, or whose dietary habit is extremely irregular.
4 A person with medical history or current illness of hepatic disorder.
5 A person with severe anemia.
6 A person with medical history of epileptic stroke, diabetes, thyroid dysfunction or severe renal dysfunction(hemodialysis, uremia, anuria), or attending the hospital regularly for these disorder.
7 A person who has taken a neuropsychological test at hospital.
8 A person who joins other human clinical study.
9 A person who is routinely taking medicines (e.g. antipsychotic, antianxiety agent, antidepressant, antiparkinson agent, antimanic agent, anticonvulsant, anticoagulant agent) which possibly affects the test results.
10 A person who is routinely taking health foods (supplements effective for antioxidative, blood flow-ameliorating and so on) which possibly affects the test results.
11 A person who is judged inappropriate to join the study by doctor in charge. (Subject who is judged inappropriate during this test is excluded from targets of analysis. In addition, a criterion not in screening criteria is not included in exclusion criteria for screening.)
12 A person who have taken an RBANS test in 3 month before main test schedule.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Ko MASUDA
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization MARUDAI FOOD 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
Address
Tel
Email

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
2016 Year 11 Month 08 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
2016 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 08 Day
Last modified on
2017 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028474

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.