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Brassica Intake and Isothiocyanate Absorption

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ClinicalTrials.gov Identifier: NCT02346812
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
Janet Novotny, USDA Beltsville Human Nutrition Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Controlled diet without brassica vegetables Other: Controlled diet with brassica vegetables Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Official Title: Brassica Intake and Isothiocyanate Absorption: Intake Patterns May Have Implications for Cancer Prevention by Dietary Brassica Vegetables
Study Start Date : January 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: Brassica
Brassica vegetables will be consumed daily as part of a controlled diet.
Other: Controlled diet with brassica vegetables
Participants will be fed a controlled diet containing foods of a typical American diet.

Control
Typical American diet will be consumed, without any Brassica vegetables.
Other: Controlled diet without brassica vegetables
Participants will be fed a controlled diet containing foods of a typical American diet.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02346812


Locations
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United States, Maryland
US Department of Agriculture Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janet Novotny, Research Physiologist, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT02346812     History of Changes
Other Study ID Numbers: HS49
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
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Phenethyl isothiocyanate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticarcinogenic Agents
Protective Agents
Physiological Effects of Drugs
Antineoplastic Agents