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

Tracking Information
First Submitted Date  ICMJE December 19, 2016
First Posted Date  ICMJE January 6, 2017
Last Update Posted Date May 25, 2017
Actual Study Start Date  ICMJE February 27, 2017
Actual Primary Completion Date May 19, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03013465 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers
Official Title  ICMJE Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Control Diet
    Participants will receive a controlled diet (base diet), typical of an American diet, with 0 g/day of broccoli (control).
    Intervention: Other: Control Diet
  • Active Comparator: Brassica Diet
    Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily.
    Intervention: Other: Base Diet with Broccoli
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2017)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 19, 2017
Actual Primary Completion Date May 19, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03013465
Other Study ID Numbers  ICMJE HS55
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Craig Charron, USDA Beltsville Human Nutrition Research Center
Study Sponsor  ICMJE USDA Beltsville Human Nutrition Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account USDA Beltsville Human Nutrition Research Center
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP