Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers

May 23, 2017 updated by: Craig Charron, USDA Beltsville Human Nutrition Research Center
The objectives of the study are 1) to determine the influence of daily consumption of well-cooked broccoli on plasma and urinary glucosinolate metabolites, and 2) to determine inflammatory marker changes consistent with decreased cancer risk.

Study Overview

Status

Completed

Conditions

Detailed Description

Consumption of Brassica vegetables is inversely associated with incidence of several cancers, including cancer of the lung, stomach, liver, colon, rectum, breast, endometrium, and ovaries. Brassica vegetables are a good source of many nutrients, but the unique characteristic of Brassicas (Broccoli in particular) is their rich content of glucosinolates. Glucosinolates are sulfur-containing compounds that are converted to isothiocyanates (ITC) by an enzyme in the plant called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. The isothiocyanates are considered to be the active agent for cancer prevention. Some of the mechanisms by which isothiocyanates likely inhibit cancer include modulation of cytochrome P450 enzymes, induction of phase II enzymes, and apoptosis.

The aim of this study is to investigate how daily consumption of broccoli with myrosinase inactivated by cooking influences glucosinolate metabolism and absorption, and consequent regulation of inflammatory markers.

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

    • Maryland
      • Beltsville, Maryland, United States, 20705
        • USDA-ARS, 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

17 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non tobacco user
  • Cancer Free
  • Not currently taking glucosinolate/isothiocyanate containing supplements

Exclusion Criteria:

  • 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 (anisinidione)
  • History of bariatric surgery or nutrient malabsorption disease
  • Pregnant, lactating, or intending to become pregnant during the study period
  • Crohn's disease or diverticulitis
  • Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
  • 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)

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control Diet
Participants will receive a controlled diet (base diet), typical of an American diet, with 0 g/day of broccoli (control).
Participants will receive a controlled diet with 0 g/d of broccoli. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
Other Names:
  • Base Diet
Active Comparator: Brassica Diet
Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily.
Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in glucosinolate metabolites will be measured in blood plasma and urine
Time Frame: At end of diet period 1 (week 3) and at the end of diet period 2 (week 12)
To track the change of endogenous broccoli isothiocyanates in this crossover study, glucosinolate metabolites will be measured in both blood plasma and urine
At end of diet period 1 (week 3) and at the end of diet period 2 (week 12)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition will be determined by dual energy x-ray absorptiometry (DEXA)
Time Frame: Day 0, just prior to beginning the controlled diet
Determine fat, lean, and bone mineral mass, and visceral fat deposition in our subjects
Day 0, just prior to beginning the controlled diet
The ability of fecal microbiota to metabolize glucosinolates will be determined
Time Frame: once per week during diet periods 1 and 2 (weeks 1, 2, 3, 10, 11, and 12)
Fecal samples will be presented with glucoraphanin to determine the ability of fecal microbes to metabolize it
once per week during diet periods 1 and 2 (weeks 1, 2, 3, 10, 11, and 12)
Fecal microbiota will be analyzed for microbial DNA
Time Frame: once at the beginning and end of diet periods 1 and 2 (weeks 1, 3, 10, and 12)
Fecal microbial communities will be determined using DNA extracted from fecal samples
once at the beginning and end of diet periods 1 and 2 (weeks 1, 3, 10, and 12)
Markers of gut health will be analyzed in blood
Time Frame: once in the third week of diet periods 1 and 2 (weeks 3 and 12)
Zonulin in blood serum will be measured by ELISA
once in the third week of diet periods 1 and 2 (weeks 3 and 12)
Markers of inflammation will be measured in blood
Time Frame: at end of diet period 1 (week 3) and at end of diet period 2 (week 12)
Cytokines and acute phase proteins will be measured in blood
at end of diet period 1 (week 3) and at end of diet period 2 (week 12)

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 (Actual)

February 27, 2017

Primary Completion (Actual)

May 19, 2017

Study Completion (Actual)

May 19, 2017

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • HS55

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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