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Completed

NCT Number: NCT02656420

Broccoli Sprout Dose Response: Bioavailability and Effects of Air Pollutants

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.

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Key information

Conditions

Environmental Carcinogenesis

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Qidong Liver Cancer Institute

Qidong, Jiangsu, 226200, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Broccoli Sprout-derived Beverage

Drug

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

Placebos

Drug

Placebo as comparison to broccoli sprout-derived beverages

Primary outcomes

  1. Sulforaphane Bioavailability Measured in Sequential 12-Hour Urine Samples

    Time frame: 10 days

    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 outcomes

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

    Time frame: 10 days

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Cancer Institute (NCI)
  • Qidong Liver Cancer Institute

Registry information

Official study title

Broccoli Sprout Dose Response: Bioavailability and Effects on Air Pollutants

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2016
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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