Oxidative Stress and Harmful Constituent Levels Associated With Little Cigars
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 8-isoprostanes Concentration in Exhaled Breath Condensate
研究概览
简要总结
Determine the effects of little cigars on human exposure to tobacco smoke oxidants. In a balanced randomized cross-over study design in cigarette smokers, subjects will be assigned to 3 exposure groups. These include a high oxidant little cigar exposure condition, a low oxidant little cigar exposure condition, and their usual cigarette. Biological samples will be collected before and after product usage.
详细描述
Exhaled breath condensate samples will be collected at pre-product usage, post-product usage, 30, and 60 minutes. Samples will be analyzed for levels of oxidant markers including 8-isoprostanes, 8-OHdG acrolein adducts and C-reactive protein.
Exhaled breath samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for levels of oxidant markers in Volitive Organic Compound (VOC) profiles.
Blood samples will be collected at pre-product usage and post-product usage. Samples will be analyzed nicotine, 8-isoprostane and other oxidative makers of stress.
Buccal cell samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts.
Salvia samples will be collected at pre-product usage and post-product usage. Samples will be analyzed for 8-OHdG adducts and metabolomic profiles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 21 - 65 years old
- •Daily cigarette smoker (>= 1 cigarette per day);
- •Smoke regular, filtered cigarettes or machine rolled cigarettes with a filter
- •No current or past use of Little Cigars
- •All other forms of nicotine must be used <6 days out of the past 30 days.
- •Able to read and write in English
- •No serious cigarette smoking quit attempt or use of any FDA-approved smoking cessation medication in the prior 30 days
- •No plan to quitting smoking in the next 3 months
排除标准
- •Women who are pregnant and/or nursing or trying to become pregnant
- •Unstable or significant medical condition in the past 3 months (e.g., recent heart attack or other serious heart condition, stroke, severe angina)
- •Respiratory diseases (e.g., exacerbations of asthma or Chronic Obstructive Pulmonary Disease (COPD), require oxygen, require oral prednisone), kidney (e.g., dialysis) or liver disease (e.g., cirrhosis), severe immune system disorders (e.g., uncontrolled HIV/AIDS, multiple sclerosis symptoms) or any medical disorder/medication that may affect participant safety or biomarker data
- •Uncontrolled substance abuse or inpatient treatment for that condition in the past 6 months
- •Exhaled Carbon Monoxide (CO) measurement of >= 17 parts per million
研究组 & 干预措施
Group A
Subjects will be given the high oxidant little cigar for their first laboratory visit. They will then be given the low oxidant little cigar for the second visit followed by using their own cigarette at the final laboratory visit.
干预措施: High Oxidant Little Cigar (Other)
Group A
Subjects will be given the high oxidant little cigar for their first laboratory visit. They will then be given the low oxidant little cigar for the second visit followed by using their own cigarette at the final laboratory visit.
干预措施: Low Oxidant Little Cigar (Other)
Group A
Subjects will be given the high oxidant little cigar for their first laboratory visit. They will then be given the low oxidant little cigar for the second visit followed by using their own cigarette at the final laboratory visit.
干预措施: Usual Cigarette (Other)
Group B
Subjects will be given the low oxidant little cigar for their first laboratory visit. They will then use their own cigarette for the second visit followed by being given the high oxidant little cigar at the final laboratory visit.
干预措施: Usual Cigarette (Other)
Group C
Subjects will use their own cigarette for their first laboratory visit. They will then be given the high oxidant little cigar for the second visit followed by being given the low oxidant little cigar at the final laboratory visit.
干预措施: High Oxidant Little Cigar (Other)
Group B
Subjects will be given the low oxidant little cigar for their first laboratory visit. They will then use their own cigarette for the second visit followed by being given the high oxidant little cigar at the final laboratory visit.
干预措施: High Oxidant Little Cigar (Other)
Group B
Subjects will be given the low oxidant little cigar for their first laboratory visit. They will then use their own cigarette for the second visit followed by being given the high oxidant little cigar at the final laboratory visit.
干预措施: Low Oxidant Little Cigar (Other)
Group C
Subjects will use their own cigarette for their first laboratory visit. They will then be given the high oxidant little cigar for the second visit followed by being given the low oxidant little cigar at the final laboratory visit.
干预措施: Low Oxidant Little Cigar (Other)
Group C
Subjects will use their own cigarette for their first laboratory visit. They will then be given the high oxidant little cigar for the second visit followed by being given the low oxidant little cigar at the final laboratory visit.
干预措施: Usual Cigarette (Other)
结局指标
主要结局
8-isoprostanes Concentration in Exhaled Breath Condensate
时间窗: 0 minutes
8-isoprostanes Concentration in Exhaled Breath Condensate
时间窗: 30 minutes
8-isoprostanes Concentration in Exhaled Breath Condensate
时间窗: 60 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate
时间窗: 0 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate
时间窗: 30 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate
时间窗: 60 minutes
8-isoprostanes Concentration in Exhaled Breath Condensate
时间窗: -5 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
时间窗: -5 minutes
C-reactive Protein Concentration in Exhaled Breath Condensate
时间窗: -5 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
时间窗: 0 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
时间窗: 30 minutes
8-OHdg Acrolein Adduct Concentration in Exhaled Breath Condensate
时间窗: 60 minutes
Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples
时间窗: -5 minutes
Oxidant makers in Volitive Organic Compound Profiles in Exhaled Breath Samples
时间窗: 0 minutes
Nicotine concentration in Blood Samples
时间窗: -5 minutes
Nicotine concentration in Blood Samples
时间窗: 0 minutes
8-isoprostanes Concentration in Blood Samples
时间窗: -5 minutes
8-isoprostanes Concentration in Blood Samples
时间窗: 0 minutes
8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples
时间窗: -5 minutes
8-OHdg Acrolein Adduct Concentration in Buccal Cell Samples
时间窗: 0 minutes
8-OHdg Acrolein Adduct Concentration in Saliva Samples
时间窗: -5 minutes
8-OHdg Acrolein Adduct Concentration in Saliva Samples
时间窗: 0 minutes
Metabolomic Profiles in Saliva Samples
时间窗: -5 minutes
Metabolomic Profiles in Saliva Samples
时间窗: 0 minutes
次要结局
未报告次要终点
研究者
Joshua Muscat
Professor, Department of Public Health Sciences
Penn State University