NCT03399656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2018

Completed
Last Updated

October 4, 2022

Status Verified

July 1, 2018

Enrollment Period

1 month

First QC Date

January 8, 2018

Last Update Submit

October 3, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Air pollution biomarkers in urine

    Consecutive overnight urine samples collected for the duration of the study (21 days)

Study Arms (3)

Placebo

PLACEBO COMPARATOR

4 placebo tablets

Dietary Supplement: Placebo tablets

Low Dose Avmacol

ACTIVE COMPARATOR

2 tablets Avmacol and 2 placebo tablets

Dietary Supplement: Avmacol tabletsDietary Supplement: Placebo tablets

High Dose Avmacol

ACTIVE COMPARATOR

4 Avmacol tablets

Dietary Supplement: Avmacol tablets

Interventions

Avmacol tabletsDIETARY_SUPPLEMENT

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.

High Dose AvmacolLow Dose Avmacol
Placebo tabletsDIETARY_SUPPLEMENT

MCC 90M Emcocel

Low Dose AvmacolPlacebo

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qidong Liver Cancer Institute

Qidong, Jiangsu, 226200, China

Location

Related Publications (1)

  • Egner PA, Chen JG, Zarth AT, Ng DK, Wang JB, Kensler KH, Jacobson LP, Munoz 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.

    PMID: 24913818BACKGROUND

Study Officials

  • Thomas W Kensler, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Placebo control
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 16, 2018

Study Start

January 10, 2018

Primary Completion

February 15, 2018

Study Completion

February 15, 2018

Last Updated

October 4, 2022

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Upon completion of biomarker analyses (January 2020)

Locations

CN(1)