Clinical trial NCT02346812: Brassica Intake and Isothiocyanate Absorption
Official title: Brassica Intake and Isothiocyanate Absorption: Intake Patterns May Have Implications for Cancer Prevention by Dietary Brassica Vegetables
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2015-01-27
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility 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

Primary outcomes:
measure: Total isothiocyanates (ITC)
timeFrame: 24-hr
Secondary outcomes:
measure: Fecal microbiota
timeFrame: End of 3-week study period
measure: Gastrointestinal health
timeFrame: 8-hr
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: US Department of Agriculture Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References:
citation: Charron CS, Vinyard BT, Ross SA, Seifried HE, Jeffery EH, Novotny JA. Absorption and metabolism of isothiocyanates formed from broccoli glucosinolates: effects of BMI and daily consumption in a randomised clinical trial. Br J Nutr. 2018 Dec;120(12):1370-1379. doi: 10.1017/S0007114518002921.