CompletedNot Applicable

Bioavailability and Mucosal Bioactivity of Avmacol® in Healthy Volunteers

10 participantsStarted 2016-06-16

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years.
✓. Members of all racial and ethnic groups are eligible.
✓. Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration.
✓. No chronic use of steroids
✓. Karnofsky Performance Scale ≥90%
✓. Able to provide written, informed consent
✓. For women of child-bearing potential (WOCBP), a negative urine pregnancy test must be documented within 7 days prior to the first study intervention
✓. Willing to avoid cruciferous vegetables during the study interventions

Exclusion criteria

✕. 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
✕. No use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4
✕. Chronic use anticoagulation

What they're measuring

Number of buccal (cheek) cells collected by participants versus a trained professional

Timeframe: 5 days

Trial details

NCT IDNCT02800265

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-06-20

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