- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02346812
Brassica Intake and Isothiocyanate Absorption
April 29, 2015 updated by: Janet Novotny, USDA Beltsville Human Nutrition Research Center
Brassica Intake and Isothiocyanate Absorption: Intake Patterns May Have Implications for Cancer Prevention by Dietary Brassica Vegetables
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Beltsville, Maryland, United States, 20705
- US Department of Agriculture Beltsville Human Nutrition Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brassica
Brassica vegetables will be consumed daily as part of a controlled diet.
|
Participants will be fed a controlled diet containing foods of a typical American diet.
|
|
Other: Control
Typical American diet will be consumed, without any Brassica vegetables.
|
Participants will be fed a controlled diet containing foods of a typical American diet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
24-hr
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fecal microbiota
Time Frame: End of 3-week study period
|
Fecal microbiota will be measured at the end of each 3-week study period.
|
End of 3-week study period
|
|
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.
|
8-hr
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
January 15, 2015
First Submitted That Met QC Criteria
January 20, 2015
First Posted (Estimate)
January 27, 2015
Study Record Updates
Last Update Posted (Estimate)
April 30, 2015
Last Update Submitted That Met QC Criteria
April 29, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- HS49
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.