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Bioavailability and Mucosal Bioactivity of Avmacol® in Healthy Volunteers

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified June 2016 by Julie E. Bauman, MD, MPH, University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Julie E. Bauman, MD, MPH, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02800265
First received: June 2, 2016
Last updated: June 14, 2016
Last verified: June 2016
  Purpose
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.

Condition Intervention
Healthy Dietary Supplement: Avmacol

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study Evaluating the Bioavailability and Mucosal Bioactivity of the Dietary Supplement, Avmacol®, in Healthy Volunteers With Optimization of Buccal Cell Biomarkers

Resource links provided by NLM:


Further study details as provided by Julie E. Bauman, MD, MPH, University of Pittsburgh:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 10
Study Start Date: June 2016
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02800265

Contacts
Contact: Julie Bauman 412-623-7833 baumanje@upmc.edu
Contact: Carrie Muniz 412-623-6121 munizca@upmc.edu

Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Julie Bauman, MD UPMC
  More Information

Responsible Party: Julie E. Bauman, MD, MPH, MD, MPH, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02800265     History of Changes
Other Study ID Numbers: 15-204
Study First Received: June 2, 2016
Last Updated: June 14, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Julie E. Bauman, MD, MPH, University of Pittsburgh:
healthy volunteer
healthy
cancer prevention
prevention

ClinicalTrials.gov processed this record on July 21, 2017