Retinoic Acid Supplementation and Subjects With Hypercholesterolemia

NCT ID: NCT02497833

Last Updated: 2015-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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control

the participants in this arm are instruted to consume placebo capsules

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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.

treatment

the participants in this arm are instruted to consume retinoic acid capsules

Group Type EXPERIMENTAL

retinoic acid

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Di Li

Doctor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min Xia, PhD

Role: STUDY_DIRECTOR

Sun Yat-sen University

Locations

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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

Site Status

Countries

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China

Other Identifiers

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ZXYZM-2

Identifier Type: -

Identifier Source: org_study_id

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