Retinoic Acid Supplementation and Subjects With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02497833
• Other study ID #: ZXYZM-2
• Status: Completed
• Phase: Phase 0
• First received: July 8, 2015
• Last updated: July 10, 2015
• Start date: November 2014
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• retinoic acid
During the trial period, the participants are instructed to consume retinoic acid capsules twice daily (30 min after breakfast and supper).The retinoic acid capsules provided a total daily intake of 10 mg of retinoic acid.

Other:
• placebo
During the trial period, the participants are instructed to consume placebo capsules twice daily (30 min after breakfast and supper).The placebo capsules are composed of starch and pigment.

Locations

Country	Name	City	State
China	Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cholesterol efflux capacity	The cholesterol efflux capacity of the two groups at baseline and after intervention is quantified by a modified method with J774 mouse macrophages. After plated and radiolabeled with 3H-cholesterolper, J774 macrophages are incubation with cAMP and apoB-depleted serum successively. Liquid scintillation counting is used to quantify the efflux of radioactive cholesterol from the cells.	changes from baseline in cholesterol efflux capacity at 12 weeks	No
Primary	PON1 activity	PON1 activity is assayed in HDL isolated from plasma of subjects from the placebo and retinoic acid groups by using UV spectrophotometry in a 96-well plate format using phenyl acetate or paraoxon as substrates.	changes from baseline in PON1 activity at 12 weeks	No
Secondary	Lp-PLA2 activity	Lp-PLA2 activity in apoB-depleted plasma after the sedimentation of all apoB-containing lipoproteins with dextran sulfate-magnesium chloride is determined using the trichloroacetic acid precipitation procedure using 2-thio platelet-activation factor as a substrate.	changes from baseline in Lp-PLA2 activity at 12 weeks	No