Effect of Intake of Citron(Citrus Junos Siebold ex Tanaka... | NCT03332641

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

NCT03332641

Sponsor

Hanyang University

Status

Completed

Last Update Posted

Nov 17, 2017Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Hyperlipidemia

Interventions

Citron peel extract
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 7, 2017Actual

Primary Completion Date

Sep 28, 2017Actual

Completion Date

Sep 28, 2017Actual

First Submitted Date

Nov 2, 2017

First Submission Date that Met QC Criteria

Nov 2, 2017

First Posted Date

Nov 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2017

Last Update Posted Date

Nov 17, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Citron peel Extract	Experimental	Citron peel extract for 12 weeks	Dietary Supplement: Citron peel extract
Placebo	Placebo Comparator	Placebo for 12 weeks	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Citron peel extract	Dietary Supplement	Citron peel extract for 12 weeks	Citron peel Extract

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanyang University		Seoul		04763	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D006949	Hyperlipidemias

Ancestor Terms

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided