UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of brain function improvement of plasmalogen intake.
Title of the study (Brief title)	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	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
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	Ko MASUDA
Organization	SOUKEN Co., Ltd
Division name	Management Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 14 Day
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

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Publication of results	Unpublished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