An Early Phase 1 interventional study of retinoic acid and placebo in Hypercholesterolemia, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-07-15.
Sponsored by Sun Yat-sen University · Early Phase 1, Interventional, and Treatment
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.
1,267 studies on the registry are indexed under Hypercholesterolemia; 105 are open to participants now.
This study's enrollment of 130 is above the median of 100 across 1,015 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Sun Yat-sen University is the lead sponsor of 1,680 studies on the registry; 609 are open to participants now.
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Exclusion Criteria:
the participants in this arm are instruted to consume placebo capsules
Other: placebo
the participants in this arm are instruted to consume retinoic acid capsules
Dietary Supplement: 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.
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.
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
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
cholesterol efflux capacity
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
The record gives a start of Nov 2014, a primary completion of May 2015 and a completion of May 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tretinoin