Effect of Intake of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Blood Cholesterol.

November 16, 2017 updated by: Yongsoon Park, Hanyang University

A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Improvement of Blood Cholesterol

This study was conducted to investigate the effects of daily supplementation of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on improvement of Blood Cholesterol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Citron(Citrus Junos Siebold ex Tanaka) Peel Extract or a placebo group. Blood cholesterol profiles before and after the intervention.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 19-75 years with Total cholesterol 200-239 mg/dL

Exclusion Criteria:

  • Lipid lowering agent within past 6 months
  • Severe cardiovascular disease(Mvodardial infarction, stroke, etc)
  • Renal disease(Heredity hyperlipidemia, Acute/Chronic renal failure, Nephrotic syndrome, ect)
  • Cancer, Respiratory organ disease(Asthma, Chronic obstructive pulmonary disease)
  • Diabetes mellitus
  • Allergic or hypersensitive to any of the ingredients in the test products
  • History of disease that could interfere with the test products or impede their absorption
  • Under antipsychotic drugs therapy within past 2 months
  • History of alcohol or substance abuse
  • Participation in any other clinical trials within past 2 months
  • Laboratory test by show the following results
  • Pregnancy or breast feeding
  • Not Contraception(except: Surgery for female infertility)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo for 12 weeks
Dietary supplement: Placebo
Placebo for 12 weeks
Experimental: Citron peel Extract
Citron peel extract for 12 weeks
Dietary supplement: Citron peel extract
Citron peel extract for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Cholesterol
Time Frame: 12 weeks
Changes of Cholesterol were assessed before and after the intervention
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of Lipid profile
Time Frame: 12 weeks
Changes of Lipid profile were assessed before and after the intervention
12 weeks
Changes of Oxidized LDL
Time Frame: 12 weeks
Changes of Oxidized LDL were assessed before and after the intervention
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2017

Primary Completion (Actual)

September 28, 2017

Study Completion (Actual)

September 28, 2017

Study Registration Dates

First Submitted

November 2, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 16, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYI-17-060-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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