Clinical trial NCT05349604: Effect of Garlic Extracts on Changes in 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of peak systolic blood flow velocity in the common carotid arteries
timeFrame: Change of peak systolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group
measure: Change of end-diastolic blood flow velocity in the common carotid arteries
timeFrame: Change of end-diastolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group
measure: Change of diastolic and systolic blood pressure
timeFrame: Change of diastolic and systolic blood pressure before and after 60 minutes garlic extract intake basis in the experimental group
measure: Change of peak systolic blood flow velocity in the internal carotid arteries
timeFrame: Change of peak systolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group
measure: Change of end-diastolic blood flow velocity in the internal carotid arteries
timeFrame: Change of end-diastolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeongsang
country: Korea, Republic of
facility: Pusan national university Yangsan Hospital
state: Yangsan
Study officials:
References: