Effects of Onion Peel Extract on Endothelial Function
Primary Purpose
Healthy, Overweight, Obese
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Placebo
Onion peel extract
Sponsored by
About this trial
This is an interventional supportive care trial for Healthy focused on measuring Quercetin, Endothelial function, Onion peel extract, volunteers
Eligibility Criteria
Inclusion Criteria:
- age 20 to 60 years
- BMI >23 kg/m2
- abdominal circumference > 90 cm in males or >85 cm in females
Exclusion Criteria:
- hypertension (>140/90 mmHg),
- diabetes
- any cardiovascular disease,
- kidney disease,
- thyroid disease
- cerebrovascular disease
- liver disease (bilirubin level >2 mg/dl)
- pregnancy
Sites / Locations
- Kyung Hee University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Onion peel extract
Arm Description
Patients treated with placebo for 12 weeks
Patients treated with onion peel extract for 14 days
Outcomes
Primary Outcome Measures
The difference of endothelial function
The difference of forearm FMD (flow meidated dilation) achieved following study drug treatment
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02180022
First Posted
June 28, 2014
Last Updated
July 1, 2014
Sponsor
Kyunghee University Medical Center
Collaborators
Kyunghee University
1. Study Identification
Unique Protocol Identification Number
NCT02180022
Brief Title
Effects of Onion Peel Extract on Endothelial Function
Official Title
Effect of Onion Peel Extract on Endothelial Function and Endothelial Progenitor Cells in Overweight and Obese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Kyunghee University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Overweight, Obese
Keywords
Quercetin, Endothelial function, Onion peel extract, volunteers
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients treated with placebo for 12 weeks
Arm Title
Onion peel extract
Arm Type
Experimental
Arm Description
Patients treated with onion peel extract for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
After randomization, placebo was treated for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Onion peel extract
Other Intervention Name(s)
OPE
Intervention Description
After randomization, onion peel extract was treated for 12 weeks
Primary Outcome Measure Information:
Title
The difference of endothelial function
Description
The difference of forearm FMD (flow meidated dilation) achieved following study drug treatment
Time Frame
12 weeks after study drug treatment
Secondary Outcome Measure Information:
Title
The difference of EPC (endothelial progenitor cell) counts
Description
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.
Time Frame
12 weeks after study drugs treatment
Other Pre-specified Outcome Measures:
Title
The composite measure of change of blood pressure, heart rate, body weight and blood chemistry
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age 20 to 60 years
BMI >23 kg/m2
abdominal circumference > 90 cm in males or >85 cm in females
Exclusion Criteria:
hypertension (>140/90 mmHg),
diabetes
any cardiovascular disease,
kidney disease,
thyroid disease
cerebrovascular disease
liver disease (bilirubin level >2 mg/dl)
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weon Kim, MD, PhD
Organizational Affiliation
Kyung Hee University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effects of Onion Peel Extract on Endothelial Function
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