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OpenTrials
Completed

NCT Number: NCT03773497

Bioavailability of Phytonutrients From Novel Preparations of Broccoli

The primary objective of this study is to determine the effects of different methods of broccoli preparation on levels of urinary glucosinolate metabolites. The secondary objective is to determine the effects of different methods of broccoli preparation on levels of plasma carotenoids.

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Key information

Conditions

Age range

21 year–75 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 (which include broccoli, cabbage, and kale) is inversely associated with the incidence of several cancers, including cancers of the lung, stomach, liver, colon, rectum, breast, endometrium, and ovaries. Brassica vegetables are a good source of many nutrients including glucosinolates and carotenoids. Glucosinolates are sulfur-containing compounds that are converted to bioactive metabolites by an enzyme called myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing or cutting. These bioactive compounds are considered to be active agents for cancer prevention. Their ability to reduce risk of cancer may derive in part from their ability to modulate foreign-substance metabolizing enzymes, which include enzymes called Phase I cytochrome P450s and Phase II enzymes. Carotenoids may also have a role in cancer prevention and other health benefits including reducing age-related macular degeneration, and therefore merit research to reveal factors that affect their presence in the body.

The primary aim of this study is to investigate how various preparations of broccoli impact levels of these healthful nutrients in humans.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Between 21 and 75 years old at beginning of study

Exclusion criteria

  • Pregnant, lactating, or intending to become pregnant during the study period
  • Women who have given birth during the previous 12 months
  • Presence of kidney disease, liver disease, gout, certain cancers, gastrointestinal disease, hyperthyroidism, untreated or unstable hypothyroidism, pancreatic disease, other metabolic diseases, or malabsorption syndromes requiring special diets
  • History of certain cancers within last 3 years
  • Known allergy or intolerance to Brassica vegetables
  • History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low-fat diets, high-protein diets)
  • Colonoscopy during three weeks prior to start of study
  • Unwillingness to abstain from probiotics or vitamin, mineral, herbal and glucosinolate/isothiocyanate supplements for two weeks prior to the study and during the study
  • Use of tobacco products within 6 months preceding study
  • Crohn's disease or diverticulitis
  • Suspected or known strictures, fistulas or physiological/mechanical GI obstruction
  • Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
  • Type 2 diabetes requiring the use of diabetes pills, insulin, or non-insulin shots
  • Fasting glucose greater than or equal to 126 mg/dL
  • Unable or unwilling to give informed consent or communicate with study staff
  • Self-report of alcohol or substance abuse within the past 12 months and/or current treatment for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Treatment and study plan

Common Snack Combination

Other

Combination of Chips, Pretzels, and Popcorn.

Cheesy Broccoli Snack

Other

Oven-roasted, freeze-dried, cheese flavored broccoli

Cheesy Broccoli with Daikon Radish Snack

Other

Oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder

Uncooked Broccoli Snack

Other

Uncooked, freeze-dried broccoli with ranch-type dip

Primary outcomes

  1. Glucosinolate Metabolites will be measured

    Time frame: Day 1

    Urine will be analyzed for glucosinolate metabolites

  2. Glucosinolate Metabolites will be measured

    Time frame: Day 22

    Urine will be analyzed for glucosinolate metabolites

  3. Glucosinolate Metabolites will be measured

    Time frame: Day 43

    Urine will be analyzed for glucosinolate metabolites

  4. Glucosinolate Metabolites will be measured

    Time frame: Day 64

    Urine will be analyzed for glucosinolate metabolites

Secondary outcomes

  1. Carotenoids will be measured

    Time frame: Days 1, 2, 3, 4, 11, 22, 23, 24, 25, 32, 43, 44, 45, 46, 53, 64, 65, 66, 67, 74

    Carotenoids will be extracted from plasma

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2018
Registry last updated
Sep 3, 2019

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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