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

NCT02115724 | Active Not Recruiting DMC

• 2 other identifiers: NO-Stress Pro000018875P01HL069999
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Acute Change in Flow mediated dilation

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

  Change from baseline (2 hours)

Secondary Outcomes (3)

• Acute Change in Biomarkers of oxidative stress

  Change from baseline (2 hours)

• Acute Change in Arterial Stiffness

  Change from baseline (2 hours)

• Acute change in Flow mediated dilation

  Immediate

Study Arms (2)

Antioxidant Cocktail

EXPERIMENTAL

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; Other: Placebo; Drug: NMD; 0.4mg sub-lingual nitroglycerin spray

Biopsy

OTHER

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

Interventions

Antioxidant cocktail DIETARY_SUPPLEMENT

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

Also known as: Vitamin C, Vitamin E, Alpha Lipoic Acid

Antioxidant Cocktail

Biopsy OTHER

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

Biopsy

Placebo OTHER

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

Antioxidant Cocktail

NMD; 0.4mg sub-lingual nitroglycerin spray DRUG

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

Also known as: Generic name: Nitrolingual, Manufacturer: Arbor Pharmaceuticals

Antioxidant Cocktail

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• documented childhood SES
• men and premenopausal women ages 18-40
• lean/overweight/or obese with BMI\< or equal to 39kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Georgia Prevention Institute , Georgia Regents University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Stress, Psychological

Interventions

Ascorbic Acid; Vitamin E; Thioctic Acid; Biopsy; Nonsense Mediated mRNA Decay

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; RNA Processing, Post-Transcriptional; Biochemical Phenomena; Chemical Phenomena; RNA Stability; Metabolism; Gene Expression Regulation; Genetic Phenomena

Study Officials

• Ryan Harris, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)