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Retinoic Acid Supplementation and Subjects With Hypercholesterolemia

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Sun Yat-sen University

Status and phase

Completed
Early Phase 1

Conditions

Hypercholesterolemia

Treatments

Other: placebo
Dietary Supplement: retinoic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT02497833
ZXYZM-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

130 participants in 2 patient groups, including a placebo group

control
Placebo Comparator group
Description:
the participants in this arm are instruted to consume placebo capsules
Treatment:
Other: placebo
treatment
Experimental group
Description:
the participants in this arm are instruted to consume retinoic acid capsules
Treatment:
Dietary Supplement: retinoic acid

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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