Effects of Sulforaphane (SFN) on Immune Response to Live Attenuated Influenza Virus in Smokers and Nonsmokers
Completed · Not applicable
Conditions studied: Smoking
In brief
Vegetables such as broccoli, cauliflower, kale and cabbage are particularly rich in a plant chemical called sulforaphane (SFN) which boosts production of certain "defense" enzymes that increase the activity of antioxidants. In animals, the chemical protection from SFN helps prevent diseases associated with inflammation and cancer among others, and this is currently being studied in humans. Young broccoli sprouts have a particularly high level of SFN compared to other foods. The purpose of this research study is to learn about short term responses to live attenuated influenza virus (LAIV, administered to you via Flumist® vaccine) between smoking and nonsmoking volunteers treated with broccoli sprout homogenates ("shake") or a placebo homogenate. This will be done by obtaining a series of "nasal lavages" or rinses of your nose with salt water, as well as 3 superficial biopsies of the inside lining of your nose both before and after you receive the vaccine. Using these samples, we will measure the amount of virus and the amount of inflammation in your nose and compare how smokers and nonsmokers respond to the vaccine when they are given a broccoli sprout homogenate (high in SFN) or a placebo alfalfa spout "shake" which is low in SFN during each of 4 study visits. Subjects will be seen for a screening visit (inc. HIV test) and then randomly assigned to receive 1 of 2 homogenates. Broccoli sprout homogenate will be the the active treatment arm while the placebo arm will be alfalfa sprout homogenate. Two to 4 weeks after screening, subjects will return for 5 sequential visits (Monday-Friday). Monday-Thursday they will receive the assigned homogenate. On Tuesday, they will receive the Flumist®vaccine. Subjects will also be seen at 1 and 3 weeks post vaccine. Nasal lavage (NL), blood samples and nasal biopsies will performed prior to and after study interventions.
Key facts
- Study ID
- NCT01269723
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 51
- Starts
- 2010-12-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2014-01-29
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy adults, age 18-40 yr who are either nonsmokers OR smokers (> 0.5 pack/day);
- Willing to avoid corticosteroids and nonsteroidal anti-inflammatory medications for 1 week prior to study entry and again for 1 week prior to all remaining visits;
- Willing to avoid antioxidant vitamins and cruciferous vegetables as well as juices/drinks with vitamin supplements added for 2 days prior to Day (-1) of the protocol and throughout the subsequent study.
You may not qualify if…
- Symptomatic allergies requiring medications for at least a 2 week interval during the past year;
- Respiratory infection (cough, sore throat, sinusitis, fever etc) within prior 4 weeks;
- Current nutritional disorder such as anorexia, bulimia, irritable bowel syndrome, Crohn's disease etc;
- Pregnancy or nursing;
- Asthma (other than wheezing occurring only in childhood); immunodeficiency (HIV or other); or any chronic medical condition that, in the opinion of the investigator, would preclude subject participation;
- Current use of immunosuppressive drugs;
- History of fainting or feeling severely dizzy with blood draws;
- History of hypersensitivity, especially anaphylactic reactions, to egg proteins, gentamicin, gelatin, or arginine or with adverse reactions to previous influenza vaccinations;
- History of Guillain Barre syndrome;
- Smokers who have abnormal lung function on pulmonary function testing at the time of screening (FVC and FEV1 < 80% of that predicted based on subject age, gender, height and race);
- Subjects who will be unable to avoid contact with immunocompromised individuals for 3 weeks after receiving LAIV vaccine;
- Receipt of any type of influenza vaccine since August 2009;
- Diagnosed influenza illness since August 2009;
- History of intolerance of or aversion to broccoli.
Where it is running
- UNC Center for Environmental Medicine, Asthma and Lung Biology — Chapel Hill, North Carolina, United States
Full record on ClinicalTrials.gov
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