NCT02115724

Nitric Oxide Bioavailability and Early Life Stress (NO-Stress)

Effect of Low Childhood Socioeconomic Status (SES) on Adult Endothelial Function and Nitric Oxide Bioavailability in Vivo and ex Vivo

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Antioxidant cocktail	Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
OTHER	Biopsy	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
OTHER	Placebo	Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
DRUG	NMD; 0.4mg sub-lingual nitroglycerin spray	Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.

Timeline

• Start date: 2014-04-01
• Primary completion: 2026-12-01
• Completion: 2027-01-01
• First posted: 2014-04-16
• Last updated: 2025-01-28

Locations

1 site across 1 country: United States