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

NCT ID: NCT02115724

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2027-01-31

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Antioxidant cocktail

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Intervention Type: OTHER

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

NMD; 0.4mg sub-lingual nitroglycerin spray

Intervention Type: DRUG

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

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.

Group Type: OTHER

Biopsy

Intervention Type: 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

Interventions

Antioxidant cocktail

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

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: OTHER

Placebo

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

Intervention Type: OTHER

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.

Intervention Type: DRUG

Other Intervention Names

Vitamin C; Vitamin E; Alpha Lipoic Acid; Generic name: Nitrolingual; Manufacturer: Arbor Pharmaceuticals

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Ryan Harris

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryan Harris, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

Georgia Prevention Institute , Georgia Regents University

Augusta, Georgia, United States

Countries

United States

Other Identifiers

5P01HL069999

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NO-Stress Pro00001887

Identifier Type: -

Identifier Source: org_study_id