Hypercholesterolemia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTretinoic 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.
OTHERplacebo
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.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PON1 activity | changes from baseline in PON1 activity at 12 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Lp-PLA2 activity | changes from baseline in Lp-PLA2 activity at 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| cholesterol efflux capacity | changes from baseline in cholesterol efflux capacity at 12 weeks | 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. |
Countries
China
Outcome results
None listed