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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Common Snack Combination; Other: Cheesy Broccoli Snack; Other: Cheesy Broccoli with Daikon Radish Snack; Other: Uncooked Broccoli Snack

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • USDA-ARS Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Common snack combination; Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of a combination of common snack foods (pretzels, potato chips, and popcorn).	Other: Common Snack Combination; Combination of Chips, Pretzels, and Popcorn.
Other: Cheese broccoli; Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli.	Other: Cheesy Broccoli Snack; Oven-roasted, freeze-dried, cheese flavored broccoli
Other: Cheese broccoli with Daikon radish powder; Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder.	Other: Cheesy Broccoli with Daikon Radish Snack; Oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder
Other: Uncooked broccoli with ranch-type dip; Subjects will consume a self-chosen, low-carotenoid diet, and on the first day, with breakfast, will consume a snack of uncooked, freeze-dried broccoli with ranch-type dip.	Other: Uncooked Broccoli Snack; Uncooked, freeze-dried broccoli with ranch-type dip

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucosinolate Metabolites will be measured	Urine will be analyzed for glucosinolate metabolites	Day 1
Glucosinolate Metabolites will be measured	Urine will be analyzed for glucosinolate metabolites	Day 22
Glucosinolate Metabolites will be measured	Urine will be analyzed for glucosinolate metabolites	Day 43
Glucosinolate Metabolites will be measured	Urine will be analyzed for glucosinolate metabolites	Day 64

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotenoids will be measured	Carotenoids will be extracted from plasma	Days 1, 2, 3, 4, 11, 22, 23, 24, 25, 32, 43, 44, 45, 46, 53, 64, 65, 66, 67, 74

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2019
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): June 28, 2019

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 30, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: HS63 - Broccoli Snack Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No