Effect of Sulforaphane-rich Broccoli Sprout Homogenate on Ozone Induced Inflammation Through Modulation of NRF2

Completed · Not applicable

Conditions studied: Healthy

In brief

Purpose: To determine if modulation of NRF2 with a Sulforaphane enriched supplement modifies responses to O3. Participants: Recruitment of up to 70 healthy volunteers, ages 18-50, for completion of 36 volunteers. Procedures: This is a randomized, placebo controlled 2x2 crossover study of treatment with an NRF2 modifier versus placebo in healthy volunteers which will examine airway inflammation before and 4 hours after a 2 hour 0.4 ppm O3 exposure. Participants will be randomized to received either the NRF2 modifier, SFN oral supplement (i.e. broccoli sprout shake), or placebo (alfalfa shake) for 3 days followed by a 0.4 ppm O3 exposure for 2 hours. At least 2 weeks later subjects will return for a 2nd supplementation treatment (using the alternative supplement to that provided initially) followed by an ozone exposure identical to the initial one.

Key facts

Study ID

NCT01625130

Run by

University of North Carolina, Chapel Hill

People needed

16

Starts

2013-10-01

Expected to finish

2015-06-01

Last updated by the study team

2015-06-11

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Normal lung function, defined as (NHanes 2001 set):
• FVC of > 80 % of that predicted for gender, ethnicity, age and height; FEV1 of > 80 % of that predicted for gender, ethnicity, age and height; FEV1/FVC ratio of > .70.
• Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy;
• Willing to avoid corticosteroids and non-steroidal anti-inflammatory medications for 1 week prior the baseline screening visit and again for 1 week prior to all remaining visits;
• Willing to avoid antioxidant vitamins and cruciferous vegetables as well as juices/drinks with added vitamin supplements for 7 days prior the baseline screening visit and throughout initial dosing period and ozone challenge as well as 7 days prior to the start of the 2nd dosing period and subsequent challenge.
• Willing to abstain from caffeine for 12 hours prior to all visits.Inclusion Criteria:

You may not qualify if…

• Any chronic medical condition considered by the PI as a contraindication to the exposure study including, but not limited to, asthma, significant cardiovascular disease, diabetes, chronic renal or thyroid disease;
• Use of tricyclics and MAO inhibitors;
• Pregnancy or nursing a baby;
• Any current smoking;
• Viral upper respiratory tract infection within 2 weeks of challenge;
• Any acute infection requiring antibiotics within 2 weeks of challenge;
• Abnormal physical findings at the baseline visit:
• Abnormalities on lung auscultation Temperature > 37.8 Systolic BP>150 mm hg or < 85 mm Hg or diastolic BP>90 mm Hg or < 50 Oxygen saturation of < 94%;
• Subjects must demonstrate the ability to produce an acceptable induced sputum sample during the screening session. If the sample is unsatisfactory, the subject's participation will end at that point;
• Subjects who have been prescribed daily anti-inflammatory medications or medications for asthma will be excluded. Oral contraceptives are acceptable. Antidepressants and other medications may be permitted if in the opinion of the investigator the medication will not interfere with the study procedures or compromise safety; and if the dosage has been stable for 1 month;
• Subjects who are unwilling to refrain from strenuous physical activity for 24 hours before and after exposure;
• Current nutritional disorder such as anorexia, bulimia, irritable bowel syndrome, Crohn's disease etc;
• Current use of immunosuppressive drugs;
• History of intolerance of or aversion to broccoli;
• Inability or unwillingness of a participant to give written informed consent;
• Receipt of LAIV (Live Attenuated Influenza Vaccine), also known as FluMist®, or other live vaccine within the prior 14 days.
• Orthopedic injuries or impediments that would preclude treadmill exercise.

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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