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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02115724
Acronym
NO-Stress
Enrollment
74
Registered
2014-04-16
Start date
2014-04-30
Completion date
2027-01-31
Last updated
2025-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

Keywords

Low childhood SES, Early Life Stress, Endothelial function, Flow mediated dilation, Cardiovascular disease, Subcutaneous adipose arterioles

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.

Interventions

DIETARY_SUPPLEMENTAntioxidant cocktail

Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment

OTHERBiopsy

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

OTHERPlacebo

Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment

DRUGNMD; 0.4mg sub-lingual nitroglycerin spray

Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Augusta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Acute Change in Flow mediated dilationChange from baseline (2 hours)Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment

Secondary

MeasureTime frameDescription
Acute Change in Biomarkers of oxidative stressChange from baseline (2 hours)Nitrite/nitrate, antioxidant capacity, and 8-isoprostane at baseline and 2 hours following acute antioxidant treatment
Acute Change in Arterial StiffnessChange from baseline (2 hours)Pulse wave velocity will be determined at baseline and 2 hours following acute antioxidant treatment
Acute change in Flow mediated dilationImmediateNitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026