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Brassica Intake and Isothiocyanate Absorption

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02346812
Enrollment
18
Registered
2015-01-27
Start date
2015-01-31
Completion date
2015-04-30
Last updated
2015-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

OTHERControlled diet without brassica vegetables

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

OTHERControlled diet with brassica vegetables

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

Sponsors

USDA Beltsville Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total isothiocyanates (ITC)24-hrAt the end of each study period, total ITC equivalents will be measured in blood and urine over a 24-hour period.

Secondary

MeasureTime frameDescription
Fecal microbiotaEnd of 3-week study periodFecal microbiota will be measured at the end of each 3-week study period.
Gastrointestinal health8-hrAt 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026