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

Hyperlipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332641
• Other study ID #: HYI-17-060-1
• Status: Completed
• Phase: N/A
• First received: November 2, 2017
• Last updated: November 16, 2017
• Start date: June 7, 2017
• Est. completion date: September 28, 2017

Study information

• Verified date: November 2017
• Source: Hanyang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 28, 2017
• Est. primary completion date: September 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias

Intervention

Dietary Supplement:
• Citron peel extract
Citron peel extract for 12 weeks
• Placebo
Placebo for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Cholesterol	Changes of Cholesterol were assessed before and after the intervention	12 weeks
Secondary	Changes of Lipid profile	Changes of Lipid profile were assessed before and after the intervention	12 weeks
Secondary	Changes of Oxidized LDL	Changes of Oxidized LDL were assessed before and after the intervention	12 weeks