HealthyNCT05349604
Effect of Garlic Extracts on Changes in Blood Flow Velocity in the Carotid Artery
A study testing Garlic extracts in people with Healthy, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Garlic extracts
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Oct 2020to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Pusan national university Yangsan Hospital
Gyeongsang, Yangsan, 50610
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Garlic extracts, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garlic extractsDietary supplement
One intake in total
PlaceboDietary supplement
One intake in total
| Study group | Role | What they receive |
|---|---|---|
| Garlic extracts | Experimental | Take 450mg of Garlic extracts(Food Item Making Report Product Name: Vegetable Extract Powder No. 1905, Item Report No.: 202004980275) Receives: Dietary Supplement: Garlic extracts |
| placebo | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of peak systolic blood flow velocity in the common carotid arteries
Doppler ultrasonography is used for measurement.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change of end-diastolic blood flow velocity before and after 60 minutes garlic extract intake basis in the experimental group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start27 Oct 2020
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong-il Shin, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349604
- Sponsor's protocol ID
- 04-2020-038
- Status last verified
- Apr 2022
- First submitted
- 9 Jun 2021
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Garlic Extracts on Changes in Blood Flow Velocity in the Carotid Artery: Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05349604
- Acronym / sponsor ID
- 04-2020-038
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Garlic extracts | Experimental | Dietary Supplement: Garlic extractsTake 450mg of Garlic extracts(Food Item Making Report Product Name: Vegetable Extract Powder No. 1905, Item Report No.: 202004980275) |
| placebo | Placebo comparator | Dietary Supplement: PlaceboAs 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garlic extractsOne intake in total | Dietary supplement | Garlic extracts |
| PlaceboOne intake in total | Dietary supplement | placebo |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garlic extracts in people with Healthy, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.