Healthy Adult VolunteersBroccosproutNCT01129466
Effects of 2 Different Broccoli Sprout Containing Supplements on Nasal Cells in Healthy Volunteers
A study testing Supplement A followed by Supplement B and Supplement B followed by Supplement A in people with Healthy Adult Volunteers, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteers
- What is being tested?
- Supplement A followed by Supplement B and Supplement B followed by Supplement A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, 27599-7310
About this study
Official title: 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
Read the 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.
- Conditions
- Healthy Adult Volunteers
- Being tested
- Supplement A followed by Supplement B, Supplement B followed by Supplement A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplement A followed by Supplement BDietary 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 B followed by Supplement ADietary 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)
| Study group | Role | What they receive |
|---|---|---|
| Supplement A followed by supplement B | Active comparator | Not described Receives: Dietary Supplement: Supplement A followed by Supplement B |
| Supplement B followed by Supplement A | Active comparator | Not described Receives: Dietary Supplement: Supplement B followed by Supplement A |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in nasal cell HO-1 expression induced by two different preparations of sulforaphane (SFN)-containing nutritional supplements
Measured: 2 hours
Secondary outcomes (1)
serum SFN level
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteersStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Terry Noah, MD, University of North Carolina, Chapel Hill
- Investigators
- Terry Noah, MD, Principal investigator, University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129466
- Sponsor's protocol ID
- 10-0410
- Other IDs
- 1R01HL095163-01A2
- Acronym
- Broccosprout
- Status last verified
- Feb 2013
- First submitted
- 21 May 2010
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sulforaphane Containing Supplements on Nasal Cell Phase 2 Gene Expression in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01129466
- Acronym / sponsor ID
- Broccosprout / 10-0410
- Conditions
- Healthy Adult Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supplement A followed by Supplement BSupplement 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) | Dietary supplement | Supplement A followed by supplement B |
| Supplement B followed by Supplement ASupplement B (Broccosprout sandwich and SFN rich tea for 3 days) followed at least 2 weeks later by 3 days of Supplement A (Broccosprout homogenate) | Dietary supplement | Supplement B followed by Supplement A |
Primary outcome
the change in nasal cell HO-1 expression induced by two different preparations of sulforaphane (SFN)-containing nutritional supplements
Time frame: 2 hours
1 secondary outcome
serum SFN level
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry Noah, MD principal investigator
University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplement A followed by Supplement B and Supplement B followed by Supplement A in people with Healthy Adult Volunteers, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in nasal cell HO-1 expression induced by two different preparations of sulforaphane (SFN)-containing nutritional supplements (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2013; AzTrials last refreshed its copy on 6 Nov 2026.