- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03013465
Daily Consumption of Well-Cooked Broccoli May Affect Glucosinolate Metabolites and Inflammatory Biomarkers
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Beltsville, Maryland, United States, 20705
- USDA-ARS, Beltsville Human Nutrition Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
|---|---|
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Other: Control Diet
Participants will receive a controlled diet (base diet), typical of an American diet, with 0 g/day of broccoli (control).
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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:
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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.
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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)
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To track the change of endogenous broccoli isothiocyanates in this crossover study, glucosinolate metabolites will be measured in both blood plasma and urine
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At end of diet period 1 (week 3) and at the end of diet period 2 (week 12)
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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
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Determine fat, lean, and bone mineral mass, and visceral fat deposition in our subjects
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Day 0, just prior to beginning the controlled diet
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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)
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Fecal samples will be presented with glucoraphanin to determine the ability of fecal microbes to metabolize it
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once per week during diet periods 1 and 2 (weeks 1, 2, 3, 10, 11, and 12)
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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)
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Fecal microbial communities will be determined using DNA extracted from fecal samples
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once at the beginning and end of diet periods 1 and 2 (weeks 1, 3, 10, and 12)
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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)
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Zonulin in blood serum will be measured by ELISA
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once in the third week of diet periods 1 and 2 (weeks 3 and 12)
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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)
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Cytokines and acute phase proteins will be measured in blood
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at end of diet period 1 (week 3) and at end of diet period 2 (week 12)
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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