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Brassica Intake and Isothiocyanate Absorption

NCT ID: NCT02346812

Last Updated: 2015-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Brassica

Brassica vegetables will be consumed daily as part of a controlled diet.

Group Type EXPERIMENTAL

Controlled diet with brassica vegetables

Intervention Type OTHER

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.

Group Type OTHER

Controlled diet without brassica vegetables

Intervention Type OTHER

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

Interventions

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Controlled diet without brassica vegetables

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

Intervention Type OTHER

Controlled diet with brassica vegetables

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Janet Novotny

Research Physiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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US Department of Agriculture Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30499426 (View on PubMed)

Other Identifiers

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HS49

Identifier Type: -

Identifier Source: org_study_id