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

January 27, 2025 updated by: Ryan Harris, Augusta University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Prevention Institute , Georgia Regents University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Dietary supplement: Antioxidant cocktail
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
Other Names:
  • Vitamin E
  • Vitamin C
  • Alpha Lipoic Acid
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.
Other Names:
  • Generic name: Nitrolingual
  • Manufacturer: Arbor Pharmaceuticals
Other: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Change in Flow mediated dilation
Time Frame: Change from baseline (2 hours)
Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
Change from baseline (2 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute Change in Biomarkers of oxidative stress
Time Frame: Change from baseline (2 hours)
Nitrite/nitrate, antioxidant capacity, and 8-isoprostane at baseline and 2 hours following acute antioxidant treatment
Change from baseline (2 hours)
Acute Change in Arterial Stiffness
Time Frame: Change from baseline (2 hours)
Pulse wave velocity will be determined at baseline and 2 hours following acute antioxidant treatment
Change from baseline (2 hours)
Acute change in Flow mediated dilation
Time Frame: Immediate
Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.
Immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augusta University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Ryan Harris, PhD, Augusta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 28, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimated)

April 16, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO-Stress Pro00001887
  • 5P01HL069999 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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