Effects of Onion Peel Extract on Endothelial Function

NCT02180022 — Phase 4, Completed, 62 participants, Kyunghee University Medical Center

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

Registry	NCT02180022
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, supportive care
Enrollment	62 (Actual)
Sponsor	Kyunghee University Medical Center (Other); collaborators: Kyunghee University
Conditions	Healthy, Overweight, Obese
Interventions	Placebo, Onion peel extract (Drug)
Dates	start 2013-04-01, primary completion 2013-12-01, completion 2013-12-01, first posted 2014-07-02, last updated 2014-07-02
Locations	1 site in South Korea

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Placebo	Placebo comparator	Drug: Placebo	Patients treated with placebo for 12 weeks
Onion peel extract	Experimental	Drug: Onion peel extract	Patients treated with onion peel extract for 14 days

Placebo (Drug): After randomization, placebo was treated for 12 weeks
Onion peel extract (Drug), also known as OPE: After randomization, onion peel extract was treated for 12 weeks

+Outcome measures

Primary outcomes

The difference of endothelial function [12 weeks after study drug treatment]: The difference of forearm FMD (flow meidated dilation) achieved following study drug treatment

Secondary outcomes

The difference of EPC (endothelial progenitor cell) counts [12 weeks after study drugs treatment]: 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.

Other outcomes

The composite measure of change of blood pressure, heart rate, body weight and blood chemistry [up to 12 weeks]

+Eligibility

Sex: All, ages: 20 Years to 60 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Kyung Hee University Hospital	Seoul	South Korea

+Investigators

Weon Kim, MD, PhD, Principal investigator, Kyung Hee University Hospital