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Effects of Onion Peel Extract on Endothelial Function

K

Kyung Hee University

Status and phase

Completed
Phase 4

Conditions

Obese
Overweight
Healthy

Treatments

Drug: Placebo
Drug: Onion peel extract

Study type

Interventional

Funder types

Other

Identifiers

NCT02180022
Onion-EPC
Seoul, Korea (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

62 patients

Sex

All

Ages

20 to 60 years old

Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

62 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Patients treated with placebo for 12 weeks
Treatment:
Drug: Placebo
Onion peel extract
Experimental group
Description:
Patients treated with onion peel extract for 14 days
Treatment:
Drug: Onion peel extract

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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