Effects of 2 Different Broccoli Sprout Containing Supplements on Nasal Cells in Healthy Volunteers (Broccosprout)

Effects of Sulforaphane Containing Supplements on Nasal Cell Phase 2 Gene Expression in Healthy Volunteers.

Purpose: To compare the change in nasal cell HO-1 expression induced by two different preparations of sulforaphane (SFN)-containing nutritional supplements Participants: Healthy nonsmoking young adults, age 18-35 Procedures (methods): This pilot study will use a randomized crossover design. Subjects will be randomized to receive either the equivalent of 4 ounces/day of fresh broccoli sprouts (FBS) in food and tea, or the equivalent amount as broccoli sprout homogenates (BSH), for 3 consecutive days. Nasal lavage and blood samples will be obtained before, during and after this 3-day period. After at least a 2-week washout interval, the protocol will be repeated with the alternate supplement. The primary analysis will test the hypothesis that broccoli sprouts in food will increase HO-1 expression to a similar degree as the equivalent amount of sprouts in BSH

Study Overview

• Status: Completed
• Conditions: Healthy Adult Volunteers
• Intervention / Treatment: Dietary supplement: Supplement A followed by Supplement B; Dietary supplement: Supplement B followed by Supplement A

Detailed Description

Broccoli sprouts are a concentrated source of the potent phase 2 enzyme (antioxidant) potentiator, sulforaphane (SFN) in the form of its natural precursor, sulforaphane glucosinolate (SGS™). SFN is an isothiocyanate which has generated interest recently as a chemopreventive agent in cancer research, and as an antioxidant in inflammation research. Recently published data show that 3 days intake of broccoli sprouts in homogenate form is followed by significant upregulation of several phase 2 enzymes in nasal cells. Our group's research at the UNC Center for Environmental Medicine, Asthma and Lung Biology (CEMALB) focuses on the effects of oxidant pollutants on inflammatory and host defense responses to viral infections. One of the aims of our grant is to measure the effects of pre-treatment with SFN supplements, on nasal responses to live attenuated influenza virus vaccines. In preparation for this larger study, we here propose a pilot study comparing the effects of the published BSH supplement, vs. supplementation with foods containing fresh broccoli sprouts, on relevant nasal endpoints and serum SFN levels.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7310
      • UNC Center for Environmental Medicine, Asthma and Lung Biology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy, nonsmoking adults, age 18-35 yr
• Willing to avoid cruciferous vegetables for 1 week prior to study entry and for 2 sets of the 4 study sessions

Exclusion Criteria:

• Inability/unwillingness to avoid anti-inflammatory medications (inhaled, topical or systemic) prior to and during the study. Duration of prohibition prior to study will based on drug half life x 6 (ie 1 day for ibuprofen, 4 days for naproxen etc);
• Inability/unwillingness to avoid antioxidant vitamins and juices or drinks with vitamin supplements added for 2 days prior to enrollment and throughout the study;
• History or symptoms of allergic rhinitis;
• 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 including corticosteroids.
• Lactose and/or gluten deficiency
• History of fainting or feeling severely dizzy with blood draws

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Supplement A followed by supplement B	Dietary supplement: Supplement A followed by Supplement B; Supplement A (3 days of Broccosprout homogenate) will be followed at least 2 weeks later by Supplement B (3 days of Broccosprout sandwich and SFN rich tea)
Active Comparator: Supplement B followed by Supplement A	Dietary supplement: Supplement B followed by Supplement A; Supplement B (Broccosprout sandwich and SFN rich tea for 3 days) followed at least 2 weeks later by 3 days of Supplement A (Broccosprout homogenate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the change in nasal cell HO-1 expression induced by two different preparations of sulforaphane (SFN)-containing nutritional supplements	2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
serum SFN level	3 days

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Terry Noah, MD, University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: May 21, 2010
• First Submitted That Met QC Criteria: May 21, 2010
• First Posted (Estimate): May 24, 2010

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 13, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 10-0410; 1R01HL095163-01A2 (U.S. NIH Grant/Contract)