NCT02656420

Brief Summary

This study will examine the extent to which lower doses of a broccoli-derived beverage enhance the detoxication of air pollutants excreted in urine as compared to an maximal dose shown to be effective previously.

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 phase_1

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

January 1, 2016

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

May 1, 2019

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

January 5, 2016

Results QC Date

July 19, 2018

Last Update Submit

April 10, 2019

Conditions

Environmental Carcinogenesis

Outcome Measures

Primary Outcomes (1)

  • Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples

    Urinary excretion of broccoli-derived sulforaphane metabolites: sulforaphane-mercapturic acid. The metabolites were measured all 20 of the sequential 12-hour urine collections from each participant over the 10-day intervention period. Data from each individual were summed to provide a single "per 24-hours" value for each participant.

    10 days

Secondary Outcomes (1)

  • Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples

    10 days

Study Arms (4)

Placebos

PLACEBO COMPARATOR

Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.

Drug: Placebos

High Dose Broccoli Sprout

EXPERIMENTAL

Beverage (100 mL) containing glucoraphanin-rich (600 micromole) and sulforaphane-rich (40 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.

Drug: Broccoli Sprout-derived Beverage

Medium Dose Broccoli Sprout

EXPERIMENTAL

Beverage (100 mL) containing glucoraphanin-rich (300 micromole) and sulforaphane-rich (20 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.

Drug: Broccoli Sprout-derived Beverage

Low Dose Broccoli Sprout

EXPERIMENTAL

Beverage (100 mL) containing glucoraphanin-rich (120 micromole) and sulforaphane-rich (8 micromole) broccoli sprout powder mixed in pineapple juice, lime juice and water. Nightly for 10 days.

Drug: Broccoli Sprout-derived Beverage

Interventions

Broccoli Sprout-derived BeverageDRUG

Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.

High Dose Broccoli SproutLow Dose Broccoli SproutMedium Dose Broccoli Sprout
PlacebosDRUG

Placebo as comparison to broccoli sprout-derived beverages

Placebos

Eligibility Criteria

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

You may qualify if:

  • in good general health with no history of chronic illness
  • normal liver function tests
  • normal renal function tests

You may not qualify if:

  • personal history of cancer except for non-melanoma skin cancer
  • use of prescribed medicines
  • for women, a positive pregnancy test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qidong Liver Cancer Institute

Qidong, Jiangsu, 226200, China

Location

Related Publications (2)

  • 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

  • Chen JG, Johnson J, Egner P, Ng D, Zhu J, Wang JB, Xue XF, Sun Y, Zhang YH, Lu LL, Chen YS, Wu Y, Zhu YR, Carmella S, Hecht S, Jacobson L, Munoz A, Kensler K, Rule A, Fahey J, Kensler T, Groopman J. Dose-dependent detoxication of the airborne pollutant benzene in a randomized trial of broccoli sprout beverage in Qidong, China. Am J Clin Nutr. 2019 Sep 1;110(3):675-684. doi: 10.1093/ajcn/nqz122.

    PMID: 31268126DERIVED

Results Point of Contact

Title
Dr. Thomas W. Kensler
Organization
JHSPH
tkensle1@jhu.edu
410-955-1292

Study Officials

  • Thomas Kensler, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 15, 2016

Study Start

January 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

May 1, 2019

Results First Posted

May 1, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)