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Completed

NCT Number: NCT02346812

Brassica Intake and Isothiocyanate Absorption

Healthy individuals (n=18) will participate in 2 controlled-feeding study periods that are 3 weeks each in length: 1) Control diet 2) Brassica diet. The control diet will consist of typical American foods and will be free of Brassica vegetables and free of glucosinolates and isothiocyanates. The Brassica diet will contain the control diet plus glucosinolate/isothiocyanate treatment foods. There will be a break of 3 weeks in between study periods. Blood, urine, and fecal samples will be collected at the end of each study period. Eligible participants will be selected based on genotype for glutathione S-transferase (GST), which has been shown to influence the potential protective role of dietary Brassicas. Half the participants (n=9) will be GSTM1-positive individuals and half (n=9) will have the GSTM1-null genotype.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

US Department of Agriculture Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 21 - 70 years of age
  • Not currently taking glucosinolate/ITC containing supplements
  • Voluntarily agree to participate and sign an informed consent document
  • Free of cancer (never diagnosed or cancer-free for at least 5 y)

Exclusion criteria

  • Pregnant, lactating, or intend to become pregnant during the study period
  • Known allergy or intolerance to Brassica vegetables
  • History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations
  • Use of tobacco products
  • Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
  • Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
  • Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)
  • Unable or unwilling to give informed consent or communicate with study staff
  • Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Treatment and study plan

Controlled diet without brassica vegetables

Other

Participants will be fed a controlled diet containing foods of a typical American diet.

Controlled diet with brassica vegetables

Other

Participants will be fed a controlled diet containing foods of a typical American diet.

Primary outcomes

  1. Total isothiocyanates (ITC)

    Time frame: 24-hr

    At the end of each study period, total ITC equivalents will be measured in blood and urine over a 24-hour period.

Secondary outcomes

  1. Fecal microbiota

    Time frame: End of 3-week study period

    Fecal microbiota will be measured at the end of each 3-week study period.

  2. Gastrointestinal health

    Time frame: 8-hr

    At the end of each 3-week study period, urine will be collected for 8 hours as part of the lactulose-mannitol test, which is a measure of gastrointestinal health.

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Official study title

Brassica Intake and Isothiocyanate Absorption: Intake Patterns May Have Implications for Cancer Prevention by Dietary Brassica Vegetables

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 27, 2015
Registry last updated
Apr 30, 2015

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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