Effects of Onion Peel Extract on Endothelial Function

Healthy Clinical Trial

Official title:

Effect of Onion Peel Extract on Endothelial Function and Endothelial Progenitor Cells in Overweight and Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180022
• Other study ID #: Onion-EPC
• Secondary ID: Seoul, Korea
• Status: Completed
• Phase: Phase 4
• First received: June 28, 2014
• Last updated: July 1, 2014
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical 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 obese subjects.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy
• Obese
• Overweight

Intervention

Drug:
• Placebo
After randomization, placebo was treated for 12 weeks
• Onion peel extract
After randomization, onion peel extract was treated for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Kyung Hee University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The composite measure of change of blood pressure, heart rate, body weight and blood chemistry		up to 12 weeks	Yes
Primary	The difference of endothelial function	The difference of forearm FMD (flow meidated dilation) achieved following study drug treatment	12 weeks after study drug treatment	No
Secondary	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.	12 weeks after study drugs treatment	No