Nitric Oxide Bioavailability and Early Life Stress (NO-Stress)
- Conditions
- Cardiovascular Disease
- Interventions
- Dietary Supplement: Antioxidant cocktailOther: BiopsyOther: Placebo
- Registration Number
- NCT02115724
- Lead Sponsor
- Augusta University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 74
- documented childhood SES
- men and premenopausal women ages 18-40
- lean/overweight/or obese with BMI< or equal to 39kg/m2
- cardiovascular, renal, pulmonary, hepatic, cerebral, or metabolic,disease
- use medications that affect vascular tone
- post menopausal women
- have class 3 obesity or BMI over 40
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Antioxidant Cocktail Antioxidant cocktail 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. Antioxidant Cocktail Placebo 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. Antioxidant Cocktail NMD; 0.4mg sub-lingual nitroglycerin spray 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. Biopsy Biopsy 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.
- Primary Outcome Measures
Name Time Method Acute Change in Flow mediated dilation Change from baseline (2 hours) Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
- Secondary Outcome Measures
Name Time Method Acute change in Flow mediated dilation Immediate Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.
Acute Change in Biomarkers of oxidative stress Change from baseline (2 hours) Nitrite/nitrate, antioxidant capacity, and 8-isoprostane at baseline and 2 hours following acute antioxidant treatment
Acute Change in Arterial Stiffness Change from baseline (2 hours) Pulse wave velocity will be determined at baseline and 2 hours following acute antioxidant treatment
Trial Locations
- Locations (1)
Georgia Prevention Institute , Georgia Regents University
🇺🇸Augusta, Georgia, United States