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
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|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Avmacol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||June 16, 2016|
|Actual Primary Completion Date :||June 20, 2016|
|Actual Study Completion Date :||June 20, 2016|
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.
- 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
- 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)
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- Willing to avoid grapefruit or grapefruit juice 48 hours prior to or during the study
- Willing to avoid daily vitamins and anti-inflammatory medications prior to and during the study
- 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.
- Willing and able to perform self-collection of buccal cells as stated in the instruction manual
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800265
|Principal Investigator:||Julie Bauman, MD||University of Pittsburgh|
|Responsible Party:||Julie E. Bauman, MD, MPH, MD, MPH, University of Pittsburgh|
|Other Study ID Numbers:||
|First Posted:||June 15, 2016 Key Record Dates|
|Last Update Posted:||November 13, 2017|
|Last Verified:||November 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
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