Bioavailability and Mucosal Bioactivity of Avmacol® in Healthy Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02800265|
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : November 13, 2017
|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)
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|