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OpenTrials
Completed

NCT Number: NCT01037465

ROS Signaling in Endothelial Function

The vascular endothelium (inner lining of cells in blood vessels) normally prevents vasospasm and thrombosis by producing nitric oxide and other regulatory substances. In patients with atherosclerosis, endothelial function is impaired. Excess production of reactive oxygen species (free radicals) contribute to endothelial dysfunction in atherosclerosis, and some prior studies have shown a beneficial effect of antioxidant treatment on endothelial function in patients with coronary artery disease. On the other hand, reactive oxygen species may be required for normal endothelial function and antioxidant supplements failed to show a benefit in large clinical trials. The effect of antioxidant treatment on endothelial function in healthy subjects is unknown. The present study will test the hypothesis that scavenging reactive species might reduce endothelium-dependent vasodilation in healthy subjects.

The study is a randomized, double-blind, placebo-controlled crossover study. Participants will receive 2.4 grams of oral NAC or similar-appearing placebo during the first visit, and then will cross over to the alternative treatment (NAC or placebo) for the second and final visit. We will examine endothelial function before and after treatment on each visit.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sex: Male and Female subjects.
  • Age range: 21-65 years old.
  • Disease status: No acute, chronic, or debilitating medical condition or use of prescribed medications.
  • Willingness and ability to provide written informed consent and the ability to understand, to participate and to comply with the study requirements.

Exclusion criteria

  • Women with a positive urine beta HCG pregnancy test and lactating women.
  • Blood pressure greater than 140/90 mmHg; serum LDL cholesterol greater than 160 mg/dl; fasting blood sugar greater than 110 mg/dl.
  • History of any cigarette smoking within one year of the study.
  • Clinical history of any acute, chronic, or debilitating medical condition, including liver disease and peptic ulcer disease.
  • Treatment with an investigational new drug within the last 30 days.
  • History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.

Treatment and study plan

N-acetylcysteine

Drug

N-acetylcysteine

Placebo

Drug

Placebo

Primary outcomes

  1. Brachial artery flow-mediated dilation

    Time frame: 4 hours

Secondary outcomes

  1. Blood markers of antioxidant capacity

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Important dates

Study start
2008
Primary completion
2015
Study completion
2016
First posted
Dec 23, 2009
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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