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Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation

This study has been completed.
Sponsor:
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
James F. Chmiel, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT01315665
First received: March 14, 2011
Last updated: February 14, 2017
Last verified: February 2017
Results First Received: December 6, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Basic Science
Condition: Cystic Fibrosis
Intervention: Dietary Supplement: Broccoli sprouts

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Healthy Volunteers

Healthy volunteers

Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.

Subjects With Cystic Fibrosis

Subjects with cystic fibrosis

Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.


Participant Flow:   Overall Study
    Healthy Volunteers   Subjects With Cystic Fibrosis
STARTED   10   5 
COMPLETED   10   5 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Healthy Volunteers

Healthy volunteers

Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.

Subjects With Cystic Fibrosis

Subjects with cystic fibrosis

Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.

Total Total of all reporting groups

Baseline Measures
   Healthy Volunteers   Subjects With Cystic Fibrosis   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   5   15 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      5 100.0%      15 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  50.0%      2  40.0%      7  46.7% 
Male      5  50.0%      3  60.0%      8  53.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      10 100.0%      5 100.0%      15 100.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   10   5   15 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Nrf2 Activation in Nasal Epithelial Cells   [ Time Frame: Baseline and of end of 5 day treatment period ]

2.  Secondary:   Measures of Lipid Peroxidation in Nasal Epithelial Cells   [ Time Frame: End of 5 day treatment period ]

3.  Secondary:   Measures of Glutathione From Blood Lymphocytes   [ Time Frame: Baseline and end of 5 day treatment period ]

4.  Secondary:   Measures of Oxidative Stress in Urine   [ Time Frame: Baseline and end of 5 day treatment period ]

5.  Secondary:   Measure of Neutrophil Migration Into the Gingival Crevices   [ Time Frame: Baseline and end of 5 day treatment period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: James Chmiel
Organization: University Hospitals Cleveland Medical Center
phone: 216-844-3267
e-mail: James.Chmiel@uhhospitals.org


Publications:


Responsible Party: James F. Chmiel, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01315665     History of Changes
Other Study ID Numbers: UHCMC-CFRC-2011-01
Study First Received: March 14, 2011
Results First Received: December 6, 2016
Last Updated: February 14, 2017