UMIN-CTR Clinical Trial

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

Healthy adults

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Shiba Palace Clinic

Institute

Department

Personal name

Organization

MARUDAI FOOD CO., LTD

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

08

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

11

Month

08

Day

Last modified on

2017

Year

05

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028474