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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Garlic extracts; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Yangsan
    • Gyeongsang, Yangsan, Korea, Republic of, 50610
      • Pusan National University Yangsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults 19 years of age or older as of the screening date
2. Those with no history of treatment for hypertension within the last 3 months
3. 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:

1. Those with systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher
2. Those who have had a stroke, myocardial infarction, percutaneous coronary angioplasty or surgery for coronary angioplasty within the past 6 months
3. Persons with acute and severe cardiovascular diseases such as heart failure, myocardial infarction, and stroke
4. Those with acute/chronic inflammation such as cancer, rheumatic disease, autoimmune disease, gastrointestinal disease, etc.
5. 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
6. Persons who have taken prohibited concomitant drugs within the last 3 months
7. Persons with a history of clinically significant hypersensitivity reactions to drugs and health functional foods
8. Those who have received antipsychotic drug treatment within 2 months before the screening test
9. Persons with a history of drug or alcohol abuse
10. Pregnant or lactating women
11. When women of childbearing potential of childbearing potential do not accept the implementation of appropriate contraceptive methods (except for women who have undergone sterilization)
12. Subjects who have participated in health functional food related research or clinical trials within the last 3 months
13. In case the principal investigator judges that it is not appropriate to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Garlic extracts; Take 450mg of Garlic extracts(Food Item Making Report Product Name: Vegetable Extract Powder No. 1905, Item Report No.: 202004980275)	Dietary supplement: Garlic extracts; One intake in total
Placebo Comparator: placebo; 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; One intake in total

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

Collaborators and Investigators

• Sponsor: Pusan National University Yangsan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 04-2020-038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No