Impact of Smoking Cessation and γ-Tocopherol to Restore Vascular Endothelial Function

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Endothelial Dysfunction

In brief

Cigarette smoking is a significant risk factor for cardiovascular disease (CVD) and is the leading cause of premature mortality in the US. The detrimental effects of smoking on vascular dysfunction are attributed to the effects of smoke itself and the inflammatory responses it induces. Smoking cessation restores vascular function by alleviating these stress responses. However, smoking cessation with nicotine replacement therapy (NRT), the prevailing approach to mitigate tobacco dependence, fails to allow full restoration of vascular function. Thus, a critical public health problem exists to understand how NRT prevents restoration of vascular function and how these NRT-mediated impairments can be overcome by using gamma-tocopherol (g-T) as an innovative co-therapy. The objective of this study is to conduct a clinical intervention trial that aims to reduce CVD risk by defining how smoking cessation and g-T restore vascular function. The hypothesis is that smoking cessation and dietary g-T supplementation will synergistically restore smoking-induced impairments in vascular function by ameliorating oxidative/nitrosative stress responses, and that g-T will facilitate full restoration of vascular function otherwise precluded by NRT. A placebo-controlled, g-T intervention study will be conducted in cigarette smokers undergoing nicotine-free or NRT smoking cessation. Prior to and after 24 h and 7 days of placebo or g-T administration, vascular function will be evaluated using a non-invasive ultrasound technique and an array of antioxidants and biomarkers for vascular inflammation and oxidative/nitrosative stress responses will be assessed. Collectively, these studies will help identify how vascular function is regulated in individuals undergoing smoking cessation, and whether g-T can be used as a strategy to better improve vascular function during smoking cessation.

Key facts

Study ID: NCT01314443
Run by: University of Connecticut
People needed: 67
Starts: 2011-01-01
Expected to finish: 2014-12-01
Last updated by the study team: 2015-01-21

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

male or female between 18-60 y,
premenopausal status for women
healthy, verified by serum clinical chemistry
stable body weight (±5 lbs) for 2-mo and BMI 19-30 kg/m2
non-nutritional supplement user for >2-mo
free of known diseases including diabetes, CVD, cancer, infections, HIV/AIDS, hepatitis, and bleeding disorders
resting blood pressure <140/90 mm Hg;
smokers (≥10 cigarettes/d, ≥1 year)
maintaining normal exercise patterns (<7 h/week) and willingness to avoid exercise 24 h prior to blood sampling and vascular testing
willingness to ingest a dietary vitamin E supplement (gamma-tocopherol; 500 mg/d) or a placebo (composed of tocopherol-free corn oil) daily for 1 week.

You may not qualify if…

serum chemistry outside normal limits
alcohol consumption >3 drinks/d or >10 drinks per week
nutritional supplement user with past 2 months
>7 hours/week of exercise
use of any pharmacological therapy to treat high cholesterol or high blood pressure
pregnancy, lactation, or initiation or change in hormonal birth control within the previous 3 mo
use of vasoactive compounds (e.g. erectile dysfunction medication, omega 3-fatty acids, niacin)
suffering from major psychiatric illnesses
currently using non-nicotine aids or drugs to quit smoking; or 10) allergy to adhesive tape.

Where it is running

University of Connecticut — Storrs, Connecticut, United States

Full record on ClinicalTrials.gov

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