Broccoli Supplement Dose Response

Healthy Volunteers Clinical Trial

Official title:

Broccoli Supplement Dose Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03399656
• Other study ID #: IRB00008184
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: February 15, 2018

Study information

• Verified date: July 2018
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 15, 2018
• Est. primary completion date: February 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Dietary Supplement:
• Avmacol tablets
The active components of Avmacol® are ground broccoli seeds that provide glucoraphanin and freeze-dried broccoli sprouts that provide a stabilized form of the enzyme myrosinase, which converts glucoraphanin to sulforaphane.
• Placebo tablets
MCC 90M Emcocel

Locations

Country	Name	City	State
China	Qidong Liver Cancer Institute	Qidong	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	Qidong Liver Cancer Institute

Country where clinical trial is conducted

China, 

References & Publications (1)

Egner PA, Chen JG, Zarth AT, Ng DK, Wang JB, Kensler KH, Jacobson LP, Muñoz A, Johnson JL, Groopman JD, Fahey JW, Talalay P, Zhu J, Chen TY, Qian GS, Carmella SG, Hecht SS, Kensler TW. Rapid and sustainable detoxication of airborne pollutants by broccoli sprout beverage: results of a randomized clinical trial in China. Cancer Prev Res (Phila). 2014 Aug;7(8):813-823. doi: 10.1158/1940-6207.CAPR-14-0103. Epub 2014 Jun 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excretion of sulforaphane and metabolites in urine	Levels of sulforaphane and its glutathione-conjugate derived metabolites will be measured in consecutive overnight urine samples	Consecutive overnight urine samples collected for the duration of the study (21 days)
Secondary	Air pollution biomarkers in urine	Levels of benzene mercapturic acid excreted in urine	Consecutive overnight urine samples collected for the duration of the study (21 days)