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

NCT01129466 | Completed

• 2 other identifiers: 10-04101R01HL095163-01A2
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (1)

• the change in nasal cell HO-1 expression induced by two different preparations of sulforaphane (SFN)-containing nutritional supplements

  2 hours

Secondary Outcomes (1)

• serum SFN level

  3 days

Study Arms (2)

Supplement A followed by supplement B

ACTIVE COMPARATOR

Dietary Supplement: Supplement A followed by Supplement B

Supplement B followed by Supplement A

ACTIVE COMPARATOR

Dietary Supplement: Supplement B followed by Supplement A

Interventions

Supplement A followed by Supplement B DIETARY_SUPPLEMENT

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)

Supplement A followed by supplement B

Supplement B followed by Supplement A DIETARY_SUPPLEMENT

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)

Supplement B followed by Supplement A

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UNC Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599-7310, United States

Location

Study Officials

• Terry Noah, MD

  University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: May 24, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

US (1)