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CompletedNCT03287115Updated Nov 21, 2017

Biomarkers of Broccoli Intake: A Pilot Study

An interventional study of Broccoli consumption in Healthy Volunteers, sponsored by USDA Beltsville Human Nutrition Research Center. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-21.

Sponsored by USDA Beltsville Human Nutrition Research Center · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
21 Years to 70 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Healthy Volunteers
03

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Non tobacco user
  • Cancer Free
  • Not currently taking glucosinolate/isothiocyanate containing supplements

Exclusion criteria

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)
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Broccoli

    Subjects will consume a dose of broccoli on day 11

    Other: Broccoli consumption

Interventions

  • OtherBroccoli consumption

    All subjects will eat broccoli on day 11

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: On Day 11

06

Study locations

1 site
  • USDA-ARS, Beltsville Human Nutrition Research Center
    Beltsville, Maryland 20705, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03287115
Lead sponsor
USDA Beltsville Human Nutrition Research Center
Responsible party
Craig Charron (Research Molecular Biologist, USDA Beltsville Human Nutrition Research Center) — Principal investigator
First posted
Sep 19, 2017
Start date
Nov 6, 2017
Primary completion
Nov 17, 2017
Completion
Nov 17, 2017
Last update
Nov 21, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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