NCT03287115

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 6, 2017

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2017

Completed
Last Updated

November 21, 2017

Status Verified

November 1, 2017

Enrollment Period

11 days

First QC Date

September 15, 2017

Last Update Submit

November 20, 2017

Conditions

Healthy Volunteers

Outcome Measures

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.

    On Day 11

Study Arms (1)

Broccoli

EXPERIMENTAL

Subjects will consume a dose of broccoli on day 11

Other: Broccoli consumption

Interventions

Broccoli consumptionOTHER

All subjects will eat broccoli on day 11

Broccoli

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Molecular Biologist

Study Record Dates

First Submitted

September 15, 2017

First Posted

September 19, 2017

Study Start

November 6, 2017

Primary Completion

November 17, 2017

Study Completion

November 17, 2017

Last Updated

November 21, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)