Back to resultsRetinoic Acid Supplementation and Subjects With Hypercholesterolemia
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
retinoic acid
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia
Eligibility Criteria
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.
Sites / Locations
- Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control
treatment
Arm Description
the participants in this arm are instruted to consume placebo capsules
the participants in this arm are instruted to consume retinoic acid capsules
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02497833
Brief Title
Retinoic Acid Supplementation and Subjects With Hypercholesterolemia
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 Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
the participants in this arm are instruted to consume placebo capsules
Arm Title
treatment
Arm Type
Experimental
Arm Description
the participants in this arm are instruted to consume retinoic acid capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
retinoic acid
Intervention Description
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
Other
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
PON1 activity
Description
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 Outcome Measure Information:
Title
Lp-PLA2 activity
Description
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
Other Pre-specified Outcome Measures:
Title
cholesterol efflux capacity
Description
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.
Time Frame
changes from baseline in cholesterol efflux capacity at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Xia, PhD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
12. IPD Sharing Statement
Learn more about this trial
Retinoic Acid Supplementation and Subjects With Hypercholesterolemia
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