Broccoli Supplement Dose Response

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Dietary Supplement: Avmacol tablets; Dietary Supplement: Placebo tablets

• Registration Number: NCT03399656
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-01-08
• Study Start: 2018-01-10
• Study First Posted: 2018-01-16
• Primary Completion: 2018-02-15
• Study Completion: 2018-02-15
• Status Verified: 2018-07
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose Avmacol	Placebo tablets	2 tablets Avmacol and 2 placebo tablets
Low Dose Avmacol	Avmacol tablets	2 tablets Avmacol and 2 placebo tablets
High Dose Avmacol	Avmacol tablets	4 Avmacol tablets
Placebo	Placebo tablets	4 placebo tablets

Primary Outcome Measures

Name	Time	Method
Excretion of sulforaphane and metabolites in urine	Consecutive overnight urine samples collected for the duration of the study (21 days)	Levels of sulforaphane and its glutathione-conjugate derived metabolites will be measured in consecutive overnight urine samples

Secondary Outcome Measures

Name	Time	Method
Air pollution biomarkers in urine	Consecutive overnight urine samples collected for the duration of the study (21 days)	Levels of benzene mercapturic acid excreted in urine

Trial Locations

Locations (1)

Qidong Liver Cancer Institute; 🇨🇳 Qidong, Jiangsu, China