Back to resultsEffect of Intake of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Blood Cholesterol.
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Citron peel extract
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hyperlipidemia
Eligibility Criteria
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)
Sites / Locations
- Hanyang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Citron peel Extract
Placebo
Arm Description
Citron peel extract for 12 weeks
Placebo for 12 weeks
Outcomes
Primary Outcome Measures
Changes of Cholesterol
Changes of Cholesterol were assessed before and after the intervention
Secondary Outcome Measures
Changes of Lipid profile
Changes of Lipid profile were assessed before and after the intervention
Changes of Oxidized LDL
Changes of Oxidized LDL were assessed before and after the intervention
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03332641
Brief Title
Effect of Intake of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Blood Cholesterol.
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
September 28, 2017 (Actual)
Study Completion Date
September 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Citron peel Extract
Arm Type
Experimental
Arm Description
Citron peel extract for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Citron peel extract
Intervention Description
Citron peel extract for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo for 12 weeks
Primary Outcome Measure Information:
Title
Changes of Cholesterol
Description
Changes of Cholesterol were assessed before and after the intervention
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes of Lipid profile
Description
Changes of Lipid profile were assessed before and after the intervention
Time Frame
12 weeks
Title
Changes of Oxidized LDL
Description
Changes of Oxidized LDL were assessed before and after the intervention
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Hanyang University
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Intake of Citron(Citrus Junos Siebold ex Tanaka) Peel Extract on Blood Cholesterol.
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