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Completed

NCT Number: NCT03013465

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Control diet

Other

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

Base Diet with Broccoli

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2017
Registry last updated
May 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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