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Bioavailability and Mucosal Bioactivity of Avmacol® in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02800265
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Julie E. Bauman, MD, MPH, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE June 2, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date November 13, 2017
Actual Study Start Date  ICMJE June 16, 2016
Actual Primary Completion Date June 20, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Number of buccal (cheek) cells collected by participants versus a trained professional [ Time Frame: 5 days ]
Number of buccal cells collected by cytobrush during week 1 (days 1-5) of the study
Original Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
Number of buccal (cheek) cells collected by participants versus a trained professional [ Time Frame: 1 week ]
Number of buccal cells collected by cytobrush during week 1 of the study
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Induction of NRF2 pathway transcripts in buccal cells by Avmacol [ Time Frame: 5 days ]
Quantitative mRNA for NQO1 in buccal cells at baseline (day 1) vs. buccal cells taken during the 3 days of Avmacol (days 2-4), and the day after Avmacol (day 5)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
Induction of NRF2 pathway transcripts in buccal cells by Avmacol [ Time Frame: 1 week ]
Quantitative mRNA for NQO1 in baseline buccal cells vs. buccal cells taken at baseline, during and after the 3 days of Avmacol (week 2 of the study)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability and Mucosal Bioactivity of Avmacol® in Healthy Volunteers
Official Title  ICMJE A Pilot Study Evaluating the Bioavailability and Mucosal Bioactivity of the Dietary Supplement, Avmacol®, in Healthy Volunteers With Optimization of Buccal Cell Biomarkers
Brief Summary Avmacol is an over-the-counter dietary supplement containing broccoli seed and sprout extracts in tablet form, hypothesized to activate protective cellular pathways including detoxication. In this study, healthy volunteers will take 3 days of Avmacol in order to evaluate both bioavailability and its bioactivity in cheek cells.
Detailed Description Avmacol is an over-the counter dietary supplement containing broccoli seed and sprout extracts in tablet form. Natural plant substances within Avmacol, called phytochemicals, are hypothesized to stimulate the body's own defense mechanisms against toxic substances commonly encountered in the environment, such as air pollution and tobacco smoke. The purpose of this study is twofold: 1) to assess the protective effects of Avmacol on the mucosa (cheek cells) of healthy volunteers, and 2) to assess the collection of cheek cells by scraping, as a less invasive method of studying drug effects in the body compared to drawing blood or a tissue biopsy. Ultimately, these results will be used to design a larger study of Avmacol in patients with tobacco-related head and neck cancer. Avmacol will be studied as a way to possibly prevent a second cancer from developing in these patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE Dietary Supplement: Avmacol
Avmacol is an over-the-counter mixture of broccoli seed and sprout extracts in tablet form to promote detoxification. These tablets contain natural substances that stimulate the body's own defense mechanisms against toxic substances commonly encountered in the environment, such as air pollution and tobacco smoke.
Other Names:
  • Sulforaphane Production System
  • broccoli seed and sprout extract
Study Arms  ICMJE Experimental: Avmacol during week 2 for 3 days

Buccal cells line the inner cheek, and will be collected from the inner right cheek with a cytobrush (a q-tip like swab) by a trained investigator.

During the second week the participant will take 8 Avmacol tablets every evening for 3 evenings (Day 2, 3, 4), and record the time of each dose in the provided diary. Research blood collection: on days 1 and 5. Overnight urine collection.

Intervention: Dietary Supplement: Avmacol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 20, 2016
Actual Primary Completion Date June 20, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Members of all racial and ethnic groups are eligible.
  3. Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration.
  4. No chronic use of steroids
  5. Karnofsky Performance Scale ≥90%
  6. Able to provide written, informed consent
  7. For women of child-bearing potential (WOCBP), a negative urine pregnancy test must be documented within 7 days prior to the first study intervention
  8. Willing to avoid cruciferous vegetables during the study interventions
  9. Willing to avoid grapefruit or grapefruit juice 48 hours prior to or during the study
  10. Willing to avoid daily vitamins and anti-inflammatory medications prior to and during the study
  11. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.
  12. Willing and able to perform self-collection of buccal cells as stated in the instruction manual

Exclusion Criteria:

  1. No current or former diagnosis of cancer, with the exception of: carcinoma-in-situ of breast or cervix; non-melanomatous skin cancer; T1-2, N0, M0 differentiated thyroid carcinoma; superficial bladder cancer; T1a or T1b prostate cancer comprising < 5% of resected tissue with normal prostate specific antigen (PSA) since resection
  2. No use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4
  3. Chronic use anticoagulation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800265
Other Study ID Numbers  ICMJE 15-204
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Julie E. Bauman, MD, MPH, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie Bauman, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP