Biomarkers of Broccoli Intake: A Pilot Study

Biomarkers of Broccoli Intake: A Pilot Study to Characterize Novel Metabolites by Targeted Metabolic Profiling and Non-Targeted Metabolomics

The objectives of the study are 1) to characterize plasma and urinary metabolites that originate from glucobrassicin, 1-methoxyglucobrassicin, 4-methoxyglucobrassicin, and 4-hydroxyglucobrassicin, which are the major indole glucosinolates found in broccoli, and 2) to identify novel plasma and urinary metabolites following broccoli consumption that may have roles in reducing the risk of cancer.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: Broccoli consumption

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. Brassicas are a good source of many nutrients, but the unique characteristic of Brassicas is their rich content of glucosinolates. Breakdown products of indole glucosinolates in Brassica vegetables show promise for reducing the risk of cancer, but have received comparatively less research attention than those of aliphatic glucosinolates. The aim of this study is to investigate plasma and urinary metabolites of indole glucosinolates from broccoli and to identify novel metabolites that may have roles in reducing cancer risk.

• Study Type: Interventional
• Enrollment (Actual): 6
• 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: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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 (anisindione)
• History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations
• 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: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Broccoli; Subjects will consume a dose of broccoli on day 11	Other: Broccoli consumption; All subjects will eat broccoli on day 11

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.	To track the changes of indole glucosinolate metabolites, glucosinolate metabolites will be measured in both blood plasma and urine.	On Day 11

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): November 17, 2017
• Study Completion (Actual): November 17, 2017

Study Registration Dates

• First Submitted: September 15, 2017
• First Submitted That Met QC Criteria: September 18, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 20, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HS58

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