Effect of Garlic Extracts on Changes in Blood Flow Velocity in the Carotid Artery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of Garlic extracts for improving of blood flow velocity in the carotid artery.

Official Title
-----------------
Effect of Garlic Extracts on Changes in Blood Flow Velocity in the Carotid Artery: Randomized, Double-blind, Placebo-controlled Study

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Garlic extracts
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adults 19 years of age or older as of the screening date Those with no history of treatment for hypertension within the last 3 months A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and fully understanding the detailed explanation of this study Exclusion Criteria: Those with systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher Those who have had a stroke, myocardial infarction, percutaneous coronary angioplasty or surgery for coronary angioplasty within the past 6 months Persons with acute and severe cardiovascular diseases such as heart failure, myocardial infarction, and stroke Those with acute/chronic inflammation such as cancer, rheumatic disease, autoimmune disease, gastrointestinal disease, etc. Those who have a history of gastrointestinal diseases (eg Crohn's disease) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of the product for human application testing Persons who have taken prohibited concomitant drugs within the last 3 months Persons with a history of clinically significant hypersensitivity reactions to drugs and health functional foods Those who have received antipsychotic drug treatment within 2 months before the screening test Persons with a history of drug or alcohol abuse Pregnant or lactating women When women of childbearing potential of childbearing potential do not accept the implementation of appropriate contraceptive methods (except for women who have undergone sterilization) Subjects who have participated in health functional food related research or clinical trials within the last 3 months In case the principal investigator judges that it is not appropriate to participate in this study

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Garlic extracts<br>Take 450mg of Garlic extracts(Food Item Making Report Product Name: Vegetable Extract Powder No. 1905, Item Report No.: 202004980275) | Dietary Supplement: Garlic extracts<br>* One intake in total<br>|
| Placebo Comparator: placebo<br>As a food ingredient that does not affect blood pressure and is harmless to the human body, it is made almost identical in weight and appearance to garlic extract. | Dietary Supplement: Placebo<br>* One intake in total<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of peak systolic blood flow velocity in the common carotid arteries | Doppler ultrasonography is used for measurement. | Change of peak systolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group | 
| Change of end-diastolic blood flow velocity in the common carotid arteries | Doppler ultrasonography is used for measurement. | Change of end-diastolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group | 
| Change of diastolic and systolic blood pressure | The blood pressure device is measured by IntelliVue MP50® from Philips. When measuring blood pressure, the study subjects should sit comfortably for at least 5 minutes and then take the measurements. The unit is mmHg and is expressed as an integer. | Change of diastolic and systolic blood pressure before and after 60 minutes garlic extract intake basis in the experimental group | 
| Change of peak systolic blood flow velocity in the internal carotid arteries | Doppler ultrasonography is used for measurement. | Change of peak systolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group | 
| Change of end-diastolic blood flow velocity in the internal carotid arteries | Doppler ultrasonography is used for measurement. | Change of end-diastolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group |