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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Terry Noah, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01129466
First received: May 21, 2010
Last updated: February 13, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention
Healthy Adult Volunteers
Dietary Supplement: Supplement A followed by Supplement B
Dietary Supplement: Supplement B followed by Supplement A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Effects of Sulforaphane Containing Supplements on Nasal Cell Phase 2 Gene Expression in Healthy Volunteers.

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • the change in nasal cell HO-1 expression induced by two different preparations of sulforaphane (SFN)-containing nutritional supplements [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum SFN level [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: May 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01129466

Locations
United States, North Carolina
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States, 27599-7310
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Terry Noah, MD University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology
  More Information

No publications provided

Responsible Party: Terry Noah, MD, Principal Investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01129466     History of Changes
Other Study ID Numbers: 10-0410, 1R01HL095163-01A2
Study First Received: May 21, 2010
Last Updated: February 13, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014