Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGarlic extracts
One intake in total
DIETARY_SUPPLEMENTPlacebo
One intake in total
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of peak systolic blood flow velocity in the common carotid arteries | Change of peak systolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group | Doppler ultrasonography is used for measurement. |
| Change of end-diastolic blood flow velocity in the common carotid arteries | Change of end-diastolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group | Doppler ultrasonography is used for measurement. |
| Change of diastolic and systolic blood pressure | Change of diastolic and systolic blood pressure before and after 60 minutes garlic extract intake basis in the experimental group | 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 peak systolic blood flow velocity in the internal carotid arteries | Change of peak systolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group | Doppler ultrasonography is used for measurement. |
| Change of end-diastolic blood flow velocity in the internal carotid arteries | Change of end-diastolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group | Doppler ultrasonography is used for measurement. |
Countries
South Korea
Outcome results
None listed