NCT02180022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
Last Updated

July 2, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

June 28, 2014

Last Update Submit

July 1, 2014

Conditions

HealthyOverweightObese

Keywords

QuercetinEndothelial functionOnion peel extractvolunteers

Outcome Measures

Primary Outcomes (1)

  • The difference of endothelial function

    The difference of forearm FMD (flow meidated dilation) achieved following study drug treatment

    12 weeks after study drug treatment

Secondary Outcomes (1)

  • The difference of EPC (endothelial progenitor cell) counts

    12 weeks after study drugs treatment

Other Outcomes (1)

  • The composite measure of change of blood pressure, heart rate, body weight and blood chemistry

    up to 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients treated with placebo for 12 weeks

Drug: Placebo

Onion peel extract

EXPERIMENTAL

Patients treated with onion peel extract for 14 days

Drug: Onion peel extract

Interventions

PlaceboDRUG

After randomization, placebo was treated for 12 weeks

Placebo
Onion peel extractDRUG

After randomization, onion peel extract was treated for 12 weeks

Also known as: OPE
Onion peel extract

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 20 to 60 years
  • BMI \>23 kg/m2
  • abdominal circumference \> 90 cm in males or \>85 cm in females

You may not qualify if:

  • hypertension (\>140/90 mmHg),
  • diabetes
  • any cardiovascular disease,
  • kidney disease,
  • thyroid disease
  • cerebrovascular disease
  • liver disease (bilirubin level \>2 mg/dl)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital

Seoul, 130-702, South Korea

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Weon Kim, MD, PhD

    Kyung Hee University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 28, 2014

First Posted

July 2, 2014

Study Start

April 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

July 2, 2014

Record last verified: 2014-06

Locations

KR(1)