Brassica Intake and Isothiocyanate Absorption

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346812
• Other study ID #: HS49
• Status: Completed
• Phase: N/A
• First received: January 15, 2015
• Last updated: April 29, 2015
• Start date: January 2015
• Est. completion date: April 2015

Study information

• Verified date: January 2015
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Controlled diet without brassica vegetables
Participants will be fed a controlled diet containing foods of a typical American diet.
• Controlled diet with brassica vegetables
Participants will be fed a controlled diet containing foods of a typical American diet.

Locations

Country	Name	City	State
United States	US Department of Agriculture Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total isothiocyanates (ITC)	At the end of each study period, total ITC equivalents will be measured in blood and urine over a 24-hour period.	24-hr	No
Secondary	Fecal microbiota	Fecal microbiota will be measured at the end of each 3-week study period.	End of 3-week study period	No
Secondary	Gastrointestinal health	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	No