HealthyPhase 4NCT02180022
Effects of Onion Peel Extract on Endothelial Function
A Phase 4 study testing Onion peel extract in people with Healthy and Overweight, run by Kyunghee University Medical Center at 1 site in South Korea.
Trial summary
Acute or chronic intake of polyphenol-rich foods has been reported to improve endothelial function. Quercetin, found abundantly in onion, is a potent antioxidant flavonoid. This study was designed to investigate whether consumption of onion peel extract (OPE) improves endothelial function in healthy overweight and… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight, Obese
- What is being tested?
- Onion peel extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Dec 2013
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 20 to 60 years
- BMI >23 kg/m2
- abdominal circumference > 90 cm in males or >85 cm in females
Who cannot join
- hypertension (>140/90 mmHg),
- diabetes
- any cardiovascular disease,
- kidney disease,
- thyroid disease
- cerebrovascular disease
- liver disease (bilirubin level >2 mg/dl)
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Onion Peel Extract on Endothelial Function and Endothelial Progenitor Cells in Overweight and Obese Subjects
Acute or chronic intake of polyphenol-rich foods has been reported to improve endothelial function. Quercetin, found abundantly in onion, is a potent antioxidant flavonoid. This study was designed to investigate whether consumption of onion peel extract (OPE) improves endothelial function in healthy overweight and obese subjects.
Read the detailed description
Epidemiological studies have shown a rapid increase in the prevalence of overweight and obesity, not only in adults but also in children and adolescents, thus increasing the risk of early development of cardiovascular disease (CVD). Quercetin, found abundantly in onion, prevents the induction of endothelial dysfunction, superoxide production, and overexpression by angiotensin II in the rat aorta. Furthermore, in our previous study we showed that supplementation with quercetin-rich onion peel extract (OPE) influenced adipokine expression, thus addressing its modulatory effect on obesity-induced inflammation, and improved insulin resistance by alleviating the metabolic dysregulation of free fatty acids, suppressing oxidative stress, upregulating glucose uptake, and downregulating inflammatory gene expression. But there are limited studies on the relationship between quercetin supplementation and endothelial dysfunction in humans.
- Conditions
- Healthy, Overweight, Obese
- Being tested
- Placebo, Onion peel extract
- Keywords
- Quercetin, Endothelial function, Onion peel extract, volunteers
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
After randomization, placebo was treated for 12 weeks
Onion peel extractDrug
Also called OPE
After randomization, onion peel extract was treated for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients treated with placebo for 12 weeks Receives: Drug: Placebo |
| Onion peel extract | Experimental | Patients treated with onion peel extract for 14 days Receives: Drug: Onion peel extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of endothelial function
The difference of forearm FMD (flow meidated dilation) achieved following study drug treatment
Measured: 12 weeks after study drug treatment
Secondary outcomes (1)
The difference of EPC (endothelial progenitor cell) counts
After appropriate gating based on low cytoplasmic granularity and low expression of CD45, CD34+VEGFR2+ cells were counted and expressed as the number of cells/106 total events or number of cells/100 µL of blood.
Measured: 12 weeks after study drugs treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyunghee University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kyunghee University
- Responsible party
- Principal investigator, Weon Kim, Kyunghee University Medical Center
- Investigators
- Weon Kim, MD, PhD, Principal investigator, Kyung Hee University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180022
- Sponsor's protocol ID
- Onion-EPC
- Other IDs
- Seoul, Korea
- Status last verified
- Jun 2014
- First submitted
- 28 Jun 2014
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Onion Peel Extract on Endothelial Function and Endothelial Progenitor Cells in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT02180022
- Acronym / sponsor ID
- Onion-EPC
- Conditions
- Healthy, Overweight, Obese
- Keywords
- Quercetin, Endothelial function, Onion peel extract, volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Kyunghee University Medical CenterUniversity, hospital or other
- Collaborators
- Kyunghee University
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Jul 2014 (estimated)
- 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.
Acute or chronic intake of polyphenol-rich foods has been reported to improve endothelial function. Quercetin, found abundantly in onion, is a potent antioxidant flavonoid. This study was designed to investigate whether consumption of onion peel extract (OPE) improves endothelial function in healthy overweight and obese subjects.
Detailed description
Epidemiological studies have shown a rapid increase in the prevalence of overweight and obesity, not only in adults but also in children and adolescents, thus increasing the risk of early development of cardiovascular disease (CVD). Quercetin, found abundantly in onion, prevents the induction of endothelial dysfunction, superoxide production, and overexpression by angiotensin II in the rat aorta. Furthermore, in our previous study we showed that supplementation with quercetin-rich onion peel extract (OPE) influenced adipokine expression, thus addressing its modulatory effect on obesity-induced inflammation, and improved insulin resistance by alleviating the metabolic dysregulation of free fatty acids, suppressing oxidative stress, upregulating glucose uptake, and downregulating inflammatory gene expression. But there are limited studies on the relationship between quercetin supplementation and endothelial dysfunction in humans.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPatients treated with placebo for 12 weeks |
| Onion peel extract | Experimental | Drug: Onion peel extractPatients treated with onion peel extract for 14 days |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 20 to 60 years
- BMI >23 kg/m2
- abdominal circumference > 90 cm in males or >85 cm in females
Key exclusion criteria (8 listed)
- hypertension (>140/90 mmHg),
- diabetes
- any cardiovascular disease,
- kidney disease,
- thyroid disease
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 |
|---|---|---|
| PlaceboAfter randomization, placebo was treated for 12 weeks | Drug | Placebo |
| Onion peel extractAlso: OPEAfter randomization, onion peel extract was treated for 12 weeks | Drug | Onion peel extract |
Primary outcome
The difference of endothelial function
Time frame: 12 weeks after study drug treatment
The difference of forearm FMD (flow meidated dilation) achieved following study drug treatment
1 secondary outcome
The difference of EPC (endothelial progenitor cell) counts
Time frame: 12 weeks after study drugs treatment
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 2 Jul 2014.
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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.
Weon Kim, MD, PhD principal investigator
Kyung Hee University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Onion peel extract in people with Healthy and Overweight, run by Kyunghee University Medical Center 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 8 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 2 Jul 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The difference of endothelial function (time frame: 12 weeks after study drug treatment). 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 2 Jul 2014.