Effects of Onion Peel Extract on Endothelial Function

NCT ID: NCT02180022

Last Updated: 2014-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-12-31

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.

Conditions

Healthy; Overweight; Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Patients treated with placebo for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

After randomization, placebo was treated for 12 weeks

Onion peel extract

Patients treated with onion peel extract for 14 days

Group Type: EXPERIMENTAL

Onion peel extract

Intervention Type: DRUG

After randomization, onion peel extract was treated for 12 weeks

Interventions

Placebo

After randomization, placebo was treated for 12 weeks

Intervention Type: DRUG

Onion peel extract

After randomization, onion peel extract was treated for 12 weeks

Intervention Type: DRUG

Other Intervention Names

OPE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kyunghee University

OTHER

Sponsor Role: collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Weon Kim

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weon Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyung Hee University Hospital

Locations

Kyung Hee University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

Seoul, Korea

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Onion-EPC

Identifier Type: -

Identifier Source: org_study_id