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Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

Primary Purpose

Environmental Carcinogenesis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Broccoli Sprout-derived Beverage
Placebos
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Environmental Carcinogenesis

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Qidong Liver Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebos

High Dose Broccoli Sprout

Medium Dose Broccoli Sprout

Low Dose Broccoli Sprout

Arm Description

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

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples
Benzene-mercapturic acid (SPMA) excretion was measured in the sequential overnight 12-hour urine samples collected across the 10-day study period. Data from each individual were summed and averaged to provide a single "per 12-hours" value for each participant.

Full Information

First Posted
January 5, 2016
Last Updated
April 10, 2019
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Qidong Liver Cancer Institute, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02656420
Brief Title
Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants
Official Title
Broccoli Sprout Dose Response: Bioavailability and Effects on Air Pollutants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Qidong Liver Cancer Institute, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a 10-day placebo control Phase II broccoli sprout intervention to be conducted in Qidong, P.R. China. Up to twelve hundred people from the farming townships will be screened and one hundred seventy eligible individuals will be enrolled in the study. Participants will be randomized into 4 treatment groups: one will receive a juice beverage containing a standard dose of glucoraphanin- and sulforaphane-rich broccoli sprout powder mixed in pineapple juice, lime juice and water, the second will receive one-half dose, the third one-fifth dose and the fourth group will receive placebo beverage containing pineapple juice, lime juice and water. Participants will drink their assigned beverage every evening and provide consecutive 12-hour urine collections throughout the duration of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Environmental Carcinogenesis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebos
Arm Type
Placebo Comparator
Arm Description
Beverage (100 mL) containing pineapple juice, lime juice and water. Nightly for 10 days.
Arm Title
High Dose Broccoli Sprout
Arm Type
Experimental
Arm Description
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.
Arm Title
Medium Dose Broccoli Sprout
Arm Type
Experimental
Arm Description
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.
Arm Title
Low Dose Broccoli Sprout
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Broccoli Sprout-derived Beverage
Intervention Description
Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo as comparison to broccoli sprout-derived beverages
Primary Outcome Measure Information:
Title
Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples
Description
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.
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Modulation of Air Pollutant Excretion in Sequential Overnight 12-Hour Urine Samples
Description
Benzene-mercapturic acid (SPMA) excretion was measured in the sequential overnight 12-hour urine samples collected across the 10-day study period. Data from each individual were summed and averaged to provide a single "per 12-hours" value for each participant.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: in good general health with no history of chronic illness normal liver function tests normal renal function tests Exclusion Criteria: personal history of cancer except for non-melanoma skin cancer use of prescribed medicines for women, a positive pregnancy test
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kensler, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qidong Liver Cancer Institute
City
Qidong
State/Province
Jiangsu
ZIP/Postal Code
226200
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24913818
Citation
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.
Results Reference
background
PubMed Identifier
31268126
Citation
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.
Results Reference
derived

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Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

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