NCT03332641

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

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

June 7, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

November 2, 2017

Last Update Submit

November 16, 2017

Conditions

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

  • Changes of Cholesterol

    Changes of Cholesterol were assessed before and after the intervention

    12 weeks

Secondary Outcomes (2)

  • Changes of Lipid profile

    12 weeks

  • Changes of Oxidized LDL

    12 weeks

Study Arms (2)

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

Citron peel extractDIETARY_SUPPLEMENT

Citron peel extract for 12 weeks

Citron peel Extract
PlaceboDIETARY_SUPPLEMENT

Placebo for 12 weeks

Placebo

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanyang University

Seoul, 04763, South Korea

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 6, 2017

Study Start

June 7, 2017

Primary Completion

September 28, 2017

Study Completion

September 28, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Locations

KR(1)