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Retinoic Acid Supplementation and Subjects With Hypercholesterolemia

Information source: Sun Yat-sen University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypercholesterolemia

Intervention: retinoic acid (Dietary Supplement); placebo (Other)

Phase: Phase 0

Status: Completed

Sponsored by: Sun Yat-sen University

Official(s) and/or principal investigator(s):
Min Xia, PhD, Study Director, Affiliation: school of public health, Sun Yat-sen University


The aim of the study is to investigate the effects of retinoic acid on the HDL-PON1 activity and cholesterol efflux capacity in hypercholesterolemic subjects.

Clinical Details

Official title: Effect of Retinoic Acid Supplementation on the HDL-Associated Paraoxonase 1 Activity in Subjects With Hypercholesterolemia: A Randomized, Double-Blinded, Placebo-Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: PON1 activity

Secondary outcome: Lp-PLA2 activity

Detailed description: Paraoxonase 1 (PON1), an enzyme associated with high-density lipoprotein, is reported to have antioxidant and cardioprotective properties. And all-trans-retinoic acid revealed the ameliorating atherosclerosis effects in many reports. There maybe some correlations between retinoic acid and PON1 activity and the study aim to prove it.


Minimum age: 25 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- subject has a fasting total cholesterol concentration between 200 and 310mg/dl.

- subject is between 25 and 65 years of age, inclusive.

- subjects' BMI is between 18. 5 kg/m2 and 35 kg/m2.

Exclusion Criteria:

- subject that is pregnant.

- subject that has coronafy artery desease, diabetes mellitus, thyroid disorders,

mental disorder, cancer, cirrhosis, renal disease and hepatic desease.

- subject that has had operation less than six months prior to screening visit.

- subject that is smoking.

- subject uses any drugs that could influence the measurement of lipid paramerters or

inflammatiory makers.

Locations and Contacts

Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus), Guangzhou, Guangdong 510080, China
Additional Information

Starting date: November 2014
Last updated: July 10, 2015

Page last updated: August 23, 2015

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