UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040493
Receipt number R000046217
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
Date of disclosure of the study information 2020/05/22
Last modified on 2022/11/11 16:50:11

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Basic information

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

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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


Base

Study type

Interventional


Study design

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



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name



Funding Source

Organization

EGAO CO.,LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)



IRB Contact (For public release)

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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

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)


Other administrative information

Date of disclosure of the study information

2020 Year 05 Month 22 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

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



Progress

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name