UMIN-CTR Clinical Trial

Public title

The verification study for the blood lipid reduction effects of garlic egg yolk: a randomized, double-blind, controlled trial

Acronym

The verification study for the blood lipid reduction effects of garlic egg yolk

Scientific Title

The verification study for the blood lipid reduction effects of garlic egg yolk: a randomized, double-blind, controlled trial

Scientific Title:Acronym

The verification study for the blood lipid reduction effects of garlic egg yolk

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the blood lipid reduction effects due to the ingestion of the test food.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

1. LDL-cholesterol
*¹ Take the blood samples at 0 week and at 6 and 12 weeks after the ingestion

Key secondary outcomes

1. Total cholesterol, HDL-cholesterol, LDL/HDL ratio, Neutral fat (triglyceride: TG), Free fatty acid, MDA-LDL
*¹ Take the blood samples at 0 week and at 6 and 12 weeks after the ingestion

2. Body weight, BMI, Body fat percentage
*² Take the measurements at 0 week and at 6 and 12 weeks after the ingestion

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

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test material:"Garlic egg yolk 229-55 ninnikugogo"
Dose: Take one capsule, three times a day
Administration: Take one capsule after each meal

Interventions/Control_2

Duration: 12 weeks
Test material: Placebo
Dose: Take one capsule, three times a day
Administration: Take one capsule after each meal

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. LDL-cholesterol level was high in the most recent health diagnosis

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. Currently taking medicines and/or herbal medicines

4. Allergic to medicines or foods related to the test food of this trial

5. Pregnant, lactating, or planning to get pregnant during the trial period

6. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial

7. Judged unsuitable for participating in this trial by physician

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Kazuo YAMAMOTO

Organization

ORTHOMEDICO, Inc.

Division name

R&D Department

Zip code

Address

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

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.

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

ORTHOMEDICO, Inc.

Institute

Department

Personal name

Organization

Temahimado Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

1. Seishin-kai Medical Association Inc, Takara Medical Clinic.

2. Evaluation Center of Health and Nutrition Inc.

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)
Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Date of disclosure of the study information

2017

Year

07

Month

28

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Suzuki N, Yamamoto K, Kakino K, Takara T. The Effects of Administration of Garlic-egg Yolk-containing Supplements on Serum Lipid Level in Humans -A Randomized, Double-blind, Placebo-controlled Trial-. Jpn Pharmacol Ther. 2016; 44(11): 1645-1653.

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

2015

Year

04

Month

21

Day

Date of IRB

Anticipated trial start date

2015

Year

04

Month

22

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

08

Month

18

Day

Last modified on

2017

Year

02

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027261