Retinoic Acid Supplementation and Subjects With Hypercholesterolemia

Early Phase 1CompletedNCT02497833

Sun Yat-sen University130 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

130

Conditions

Hypercholesterolemia

Interventions

retinoic acidDIETARY_SUPPLEMENT

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.

placeboOTHER

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 (1)

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

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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.

Time frame: changes from baseline in PON1 activity at 12 weeks

Secondary Outcomes

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.

Time frame: changes from baseline in Lp-PLA2 activity at 12 weeks

Data from ClinicalTrials.gov

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