ROS Signaling in Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01037465
Recruitment Status : Completed
First Posted : December 23, 2009
Last Update Posted : March 10, 2017
Information provided by (Responsible Party):
Naomi M Hamburg, Boston University

December 19, 2009
December 23, 2009
March 10, 2017
September 2008
December 2015   (Final data collection date for primary outcome measure)
Brachial artery flow-mediated dilation [ Time Frame: 4 hours ]
Same as current
Complete list of historical versions of study NCT01037465 on Archive Site
Blood markers of antioxidant capacity [ Time Frame: 4 hours ]
Same as current
Not Provided
Not Provided
ROS Signaling in Endothelial Function
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.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Cardiovascular Disease
  • Drug: N-acetylcysteine
  • Drug: Placebo
  • Active Comparator: N-acetylcysteine
    Intervention: Drug: N-acetylcysteine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 26, 2016
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Women with a positive urine beta HCG pregnancy test and lactating women.
  2. Blood pressure greater than 140/90 mmHg; serum LDL cholesterol greater than 160 mg/dl; fasting blood sugar greater than 110 mg/dl.
  3. History of any cigarette smoking within one year of the study.
  4. Clinical history of any acute, chronic, or debilitating medical condition, including liver disease and peptic ulcer disease.
  5. Treatment with an investigational new drug within the last 30 days.
  6. History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Naomi M Hamburg, Boston University
Boston University
Not Provided
Principal Investigator: Naomi Hamburg, MD Boston University
Boston University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP