UMIN-CTR Clinical Trial

Public title

A verification study for the reducing effect of the consumption of the test-food on LDL cholesterol

Acronym

A verification study for the reducing effect of the consumption of the test-food on LDL cholesterol

Scientific Title

A verification study for the reducing effect of the consumption of the test-food on LDL cholesterol: A randomized double-blind placebo-controlled, parallel-group trial

Scientific Title:Acronym

A verification study for the reducing effect of the consumption of the test-food on LDL cholesterol

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the reducing effects of consumption of the test-food on LDL cholesterol.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured value of LDL cholesterol at 12 weeks after the start of test-food consumption

Key secondary outcomes

1. The measured value of LDL cholesterol at four and eight weeks after the start of test-food consumption

2. The amount of changes of LDL cholesterol between before and four, eight and 12 weeks after the start of test-food consumption

3. The rate of changes of LDL cholesterol between before and four, eight and 12 weeks after the start of test-food consumption

4. The ratio of number of subjects whose LDL cholesterol levels are less than 120 mg/dL at 12 weeks after the start of test-food consumption

5-1. The measured values of the following items
5-2. The amount of changes of the following items
[Items] total cholesterol, HDL cholesterol, flow mediated dilation (FMD), maximum expansion width of vessel, diameter of vessels at rest, blood flow velocity, visibility of vessels, density of vessels, diameter of vessels, distance between vessels and length of vessels

6. The ratio of number of subjects whose blood vessels are straight and shaped like hairpins, twisted and various shapes, irregular such as branches, or look short (hard to see) after four, eight and 12 weeks after the start of test-food consumption

7. The measured values of each item of original questionnaires at four, eight and 12 weeks after the start of test-food consumption

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Capsule containing fish oil
Administration: Take three capsules per day at any time during the day.

* If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: 12 weeks
Test food: Placebo capsule
Administration: Take three capsules per day at any time during the day.

* If you forget to take the test food, take it as soon as you remember 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 subjects

2. Subjects whose LDL cholesterol level was high in the most recent health checks

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

4. Subjects whose LDL cholesterol levels are 120 mg/dL or more and 139 mg/dL or less at screening

Key exclusion criteria

1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction

2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake

5. Subjects regularly taking medications (including herbal medicines) and supplements

6. Subjects allergic to medications and/or the test-food-related products

7. Subjects who are pregnant, lactating, or intending 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 or plan to participate another trial during this trial

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

Target sample size

52

Name of lead principal investigator

1st name	Kazuo
Middle name
Last name	YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

112-0002

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	Naoko
Middle name
Last name	SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

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

EGAO CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.

Tel

03-5793-3623

Email

IRB@takara-clinic.com

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)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2020

Year

05

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

53

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

2020

Year

05

Month

13

Day

Date of IRB

2020

Year

05

Month

13

Day

Anticipated trial start date

2020

Year

05

Month

19

Day

Last follow-up date

2020

Year

12

Month

19

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

05

Month

22

Day

Last modified on

2022

Year

11

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046217