Broccoli Supplement Dose Response

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Healthy Volunteers

Treatments: Dietary Supplement: Placebo tablets; Dietary Supplement: Avmacol tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT03399656

IRB00008184

Details and patient eligibility

About

Do daily high (4 tablets) or intermediate (2 tablets) administration of the broccoli-based dietary supplement Avmacol® have improved bioavailability over a broccoli sprout beverage rich in sulforaphane and its biogenic precursor, glucoraphanin? The beverage formulation has been used successfully in the investigators' previous intervention studies in regions of China with high levels of air pollution to reduce the body burden of carcinogenic and toxic pollutants. The investigators seek to evaluate a more stable, less expensive formulation of a broccoli sprout preparation that can be used for disease prevention in future studies.

Full description

The investigators will conduct a 3-armed placebo-controlled 16-day intervention with the dietary supplement Avmacol® to determine the bioavailability with repeated dosing of a simple tablet-based intervention in the study participants. As shown in Scheme 1, the 3 arms are: 1) 4 tablets of Avmacol® daily for 14 days; 2) 2 tablets of Avmacol® daily for 14 days together with 2 placebo tablets to maintain parity in consumption; and 3) 4 placebo tablets daily for 14 days. In addition, all participants will receive 4 placebo tablets for 2 consecutive run-in days prior to commencing intervention in the 3 distinct arms. Consecutive overnight (12-hour) urine samples will be collected during the 2-day run-in, the 14-day intervention and during a 5-day run-out period (total = 21 days). Additional day-time urine collections will be made at 2 timepoints: the day after administration of Avmacol® tablets begins and the day after the last administration of Avmacol® tablets. A blood sample will be collected at the beginning of the run-in and after the last Avmacol® dose (Day 17 for intervention groups, and for the placebo group) from each participant. The tablets will be taken before dinner each day.

Enrollment: 170 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥ 21 and ≤ 70 years who are residents of Qidong, China.
2. Able to provide written, informed consent.
3. Normal physical examination and medical history indicative of good general health with no history of chronic illness.
4. No hepatomegaly by clinical exam;
5. Normal liver function tests (ALT, aspartate aminotransferase (AST), bilirubin);
6. Normal renal function tests (creatinine, blood urea nitrogen (BUN), urinalysis);
7. Serum alpha-fetoprotein (AFP) negative.

Exclusion criteria

1. Pregnant (positive human chorionic gonadotropin (HCG) strip test)
2. Current or former diagnosis of cancer, with the exception of non-melanomatous skin cancer.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

170 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

4 placebo tablets

Treatment:

Dietary Supplement: Placebo tablets

Low Dose Avmacol

Active Comparator group

Description:

2 tablets Avmacol and 2 placebo tablets

Treatment:

Dietary Supplement: Avmacol tablets

Dietary Supplement: Placebo tablets

High Dose Avmacol

Active Comparator group

Description:

4 Avmacol tablets

Treatment:

Dietary Supplement: Avmacol tablets