We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03013465
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
Craig Charron, USDA Beltsville Human Nutrition Research Center

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Control Diet Other: Base Diet with Broccoli Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : May 19, 2017
Actual Study Completion Date : May 19, 2017
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Control Diet
Participants will receive a controlled diet (base diet), typical of an American diet, with 0 g/day of broccoli (control).
 Other: Control Diet
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 Name: Base Diet
Active Comparator: Brassica Diet
Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily.
 Other: Base Diet with Broccoli
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013465


Locations
Layout table for location information
United States, Maryland
USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Craig Charron, Research Molecular Biologist, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT03013465    
Other Study ID Numbers: HS55
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No