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

Information source: Georgia Regents University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cardiovascular Disease

Intervention: Antioxidant cocktail (Dietary Supplement); Biopsy (Other); Placebo (Other); NMD; 0.4mg sub-lingual nitroglycerin spray (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Georgia Regents University

Official(s) and/or principal investigator(s):
Ryan Harris, PhD, Principal Investigator, Affiliation: Georgia Regents University

Overall contact:
Ryan Harris, PhD, Phone: 706 721-5998, Email: ryharris@gru.edu


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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Acute Change in Flow mediated dilation

Acute Change in Flow mediated dilation

Secondary outcome:

Acute Change in Biomarkers of oxidative stress

Acute Change in Arterial Stiffness

Acute change in Flow mediated dilation

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.


Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.


Inclusion Criteria:

- documented childhood SES

- men and premenopausal women ages 18-40

- lean/overweight/or obese with BMI< or equal to 39kg/m2

Exclusion Criteria:

- 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

Locations and Contacts

Ryan Harris, PhD, Phone: 706 721-5998, Email: ryharris@gru.edu

Georgia Prevention Institute , Georgia Regents University, Augusta, Georgia 30912, United States; Recruiting
Ryan Harris, PhD, Phone: 706-721-5998, Email: ryharris@gru.edu
Jacqueline Musall, BS, Phone: 706 721-8515, Email: jmusall@gru.edu
Ryan Harris, PhD, Principal Investigator
Additional Information

Starting date: April 2014
Last updated: July 17, 2015

Page last updated: August 23, 2015

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