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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349604
• Other study ID #: 04-2020-038
• Status: Completed
• Phase: N/A
• Start date: October 27, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: April 2022
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Garlic extracts
One intake in total
• Placebo
One intake in total

Locations

Country	Name	City	State
Korea, Republic of	Pusan national university Yangsan Hospital	Gyeongsang	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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