Bioavailability and Mucosal Bioactivity of Avmacol® in Healthy Volunteers

NCT02800265 | Completed DMC

• 1 other identifier: 15-204
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

healthy volunteer; healthy; cancer prevention; prevention

Outcome Measures

Primary Outcomes (1)

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

  Number of buccal cells collected by cytobrush during week 1 (days 1-5) of the study

  5 days

Secondary Outcomes (1)

• Induction of NRF2 pathway transcripts in buccal cells by Avmacol

  5 days

Study Arms (1)

Avmacol during week 2 for 3 days

EXPERIMENTAL

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

Interventions

Avmacol DIETARY_SUPPLEMENT

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.

Also known as: Sulforaphane Production System, broccoli seed and sprout extract

Avmacol during week 2 for 3 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Officials

• Julie Bauman, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 15, 2016
• Study Start: June 16, 2016
• Primary Completion: June 20, 2016
• Study Completion: June 20, 2016
• Last Updated: November 13, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share