Role of Traditional Cigarettes, Electronic and IQOS Cigarettes on Oxidative Stress.

Study Overview
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Brief Summary
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Electronic cigarettes (E-cigarettes) and new heat-not-burn tobacco products such as IQOS®, an electronic device that heats a cigarette-like stick without combustion, are a modern and technological surrogate of traditional tobacco cigarettes (T-cigarettes), that are entering in the commercial market. While the negative effects of the traditional cigarette are well known, little data are reported in scientific literature on the risks on the health by these new smoking devices. Endothelial dysfunction evaluated by flow-mediated dilatation (FMD), oxidative stress and platelet activation have been recognized as a hallmark of preclinical systemic atherosclerosis and as a useful marker to stratify the risk of cardiovascular disease in patients at risk or with established clinically significant atherosclerosis. Since no data are reported about the effects of these new smoking device on oxidative stress, platelet activation and FMD, the investigators designed a human study assessing if these new smoking devices have effects on healthy smokers.

Official Title
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Effects on Oxidative Stress and Platelet Activation of Traditional Cigarettes, E-cigarettes and IQOS Cigarettes: A Randomized in Vivo Study.

Conditions
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Oxidative Stress Induction, Endothelial Dysfunction, Platelet Activation

Intervention / Treatment
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* Behavioral: Smoke


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smokers volunteers, minimum age 18 years Exclusion Criteria: no history of acute or chronic organic, metabolic and inflammatory diseases; no fever and infections in the last 3 months; no history of cardiovascular pathological symptoms; no allergies; none of the participants took vitamin E, other antioxidant supplements or other drugs potentially affecting oxidative stress or FMD women were not menstruating when the experiment was performed.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional cigarette<br>smoke one Traditional cigarette (with a mean nicotine content of 0.6 mg according to package label) and in a sub-group smoke a sham cigarette (an traditional cigarette without combustion). | Behavioral: Smoke<br>* See arm/group descriptions.<br>|
| Experimental: Electronic cigarette<br>smoke a tobacco-flavored Electronic cigarette (9 puffs approximately equivalent to 0.6 mg of nicotine content) and in a sub-group smoke a sham cigarette (an electronic cigarette without nicotine). | Behavioral: Smoke<br>* See arm/group descriptions.<br>|
| Experimental: Heat-not-burn tobacco products (IQOS)<br>smoke one IQOS cigarette (with a mean nicotine content of 0.6 mg according to package label). | Behavioral: Smoke<br>* See arm/group descriptions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial dysfunction | flow-mediated dilatation (FMD) assessed by vascular ultrasound | up to 24 weeks | 
| Oxidative stress | Soluble Nox2-derived peptide, a direct marker of NADPH oxidase activation | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet activation | evaluation of sPselectin, thromboxane and aggregation as markers of platelet activation | up to 24 weeks |