Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioavailability of Phytonutrients From Novel Preparations of Broccoli

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: NCT03773497
Recruitment Status : Completed
First Posted : December 12, 2018
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Craig Charron, USDA Beltsville Human Nutrition Research Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Other: Common Snack Combination Other: Cheesy Broccoli Snack Other: Cheesy Broccoli with Daikon Radish Snack Other: Uncooked Broccoli Snack Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Bioavailability of Phytonutrients From Novel Preparations of Broccoli
Actual Study Start Date : April 16, 2019
Actual Primary Completion Date : June 28, 2019
Actual Study Completion Date : June 28, 2019

Arm Intervention/treatment
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.

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

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773497


Locations
Layout table for location information
United States, Maryland
USDA-ARS Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
Layout table for additonal information
Responsible Party: Craig Charron, Research Molecular Biologist, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT03773497    
Other Study ID Numbers: HS63 - Broccoli Snack Study
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No