An interventional study of Antioxidant cocktail and Biopsy in Cardiovascular Disease, sponsored by Augusta University. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-28.
Sponsored by Augusta University · Not applicable, Interventional, and Treatment
Cardiovascular disease is the leading cause of death in the United States. Other studies have shown that stress, early in life, could be a risk factor for cardiovascular disease, later in life. This study will look at the effect of early life stressors on your cardiovascular health.
This study will have two parts involved to investigate the role that childhood SES status has on cardiovascular health.
Part one: Subjects will give a blood sample which will be processed and analyzed. Flow mediated dilation (FMD) and Pulse wave velocity (PWV/PWA) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg of Vitamin C, 600 IU of Vitamin E, and 600 mg of alpha-lipoic acid) or placebo on two days separated by at least 72 hours. Nitroglycerin mediated dilation (NMD, 0.4mg sub-lingual nitroglycerin spray), will be assessed at baseline.
Part two: Subjects, if interested will undergo a subcutaneous gluteal/hip fat biopsy. Micro vessels will be isolated from the adipose tissue and analyzed by pressurized myography for endothelial function and nitric oxide bioavailability.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 74 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
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Exclusion Criteria:
Following an overnight fast, blood samples, flow-mediated dilation, and nitroglycerin mediated dilation (NMD; 0.4mg sub-lingual nitroglycerin spray) will be performed at baseline and 2 hours following either a single dose oral antioxidant cocktail (1000 mg Vitamin C, 600 IU vitamin E, 600 mg Alpha Lipoic Acid) or placebo on two days separated by at least 72 hours.
Dietary Supplement: Antioxidant cocktail · Other: Placebo · Drug: NMD; 0.4mg sub-lingual nitroglycerin spray
Following an overnight fast, a subcutaneous gluteal/hip fat biopsy sample will be obtained from each subject under local anesthesia, with adipose tissue (\~2x1.5x1.5cm) to be harvested and placed immediately in physiological saline solution (PSS): Small arteries, 100 to 150 um in diameter, will be dissected from the fat under a dissecting microscope, transferred to an arteriographic bath chamber, and cannulated for pressurized myography.
Other: Biopsy
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
Also known as: Vitamin C, Vitamin E, Alpha Lipoic Acid
Under sterile conditions, a small incision (¼ - ½ inch) by the study doctor will be made and the piece of fat will be taken out. Fat tissue was chosen for this study because it is a big source of small blood vessels which we are studying
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.
Also known as: Generic name: Nitrolingual, Manufacturer: Arbor Pharmaceuticals
Acute Change in Flow mediated dilation
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
Time frame: Change from baseline (2 hours)
Acute Change in Biomarkers of oxidative stress
Nitrite/nitrate, antioxidant capacity, and 8-isoprostane at baseline and 2 hours following acute antioxidant treatment
Time frame: Change from baseline (2 hours)
Acute Change in Arterial Stiffness
Pulse wave velocity will be determined at baseline and 2 hours following acute antioxidant treatment
Time frame: Change from baseline (2 hours)
Acute change in Flow mediated dilation
Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.
Time frame: Immediate
Plan to share: Yes
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Augusta University