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Completed

NCT Number: NCT05349604

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

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.

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Key information

Conditions

Healthy

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan national university Yangsan Hospital

Gyeongsang, Yangsan, 50610, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Garlic extracts

Dietary Supplement

One intake in total

Placebo

Dietary Supplement

One intake in total

Primary outcomes

  1. Change of peak systolic blood flow velocity in the common carotid arteries

    Time frame: 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.

  2. Change of end-diastolic blood flow velocity in the common carotid arteries

    Time frame: 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.

  3. Change of diastolic and systolic blood pressure

    Time frame: 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.

  4. Change of peak systolic blood flow velocity in the internal carotid arteries

    Time frame: 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.

  5. Change of end-diastolic blood flow velocity in the internal carotid arteries

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 27, 2022
Registry last updated
Apr 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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