UMIN-CTR Clinical Trial

Public title

The verification study for safety evaluation of excessive the test food ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study

Acronym

The verification study for safety evaluation of excessive the test food ingestion in humans

Scientific Title

The verification study for safety evaluation of excessive the test food ingestion in humans: a randomized, double-blind, placebo-controlled, parallel study

Scientific Title:Acronym

The verification study for safety evaluation of excessive the test food ingestion in humans

Region

Japan

Condition

Healthy Japanese adult people

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To identify the safety of the test food to consume 5 times more than recommended daily intake

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. Physical examination
2. Urinalysis
3. Blood test
4. Questionnaire (the Likert scale)

* Assess at screening and examination before consuming and at 2 and 4 weeks after ingestion

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: 4 weeks
Test materials: Sea squirt-derived plasmalogen capsule {Sea squirt-derived plasmalogen: 100 mg/capsule (1 mg of plasmalogen)}
Dose: 5 capsules per day
Administration: Take 5 capsules per day any time during the day

* Take 5 capsules within the day.

Interventions/Control_2

Duration: 4 weeks
Test materials: Placebo capsule
Dose: 5 capsules per day
Administration: Take 5 capsules per day any time during the day

* Take 5 capsules within the day.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese adult people

2. Subjects who are judged as eligible to participate in the study by the physician

Key exclusion criteria

1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction

2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases

3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily

4. Currently taking medicines (include herbal medicines) and supplements

5. Subjects who take DHA or/and EPA-containing food in daily

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, breast-feeding, and planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

9. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

40

Name of lead principal investigator

1st name
Middle name
Last name	Kazuo YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Email

kazu@orthomedico.jp

Name of contact person

1st name
Middle name
Last name	Naoko SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

NIHON PHARMACEUTICAL CO., LTD.
Sunsho Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

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

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Date of disclosure of the study information

2017

Year

12

Month

15

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

2017

Year

12

Month

11

Day

Date of IRB

Anticipated trial start date

2017

Year

12

Month

16

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

12

Month

15

Day

Last modified on

2018

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034734