CClinicalTrials.gg
CompletedNCT04113928Updated Oct 3, 2019

Broccoli Ileo Study

An interventional study of Broccoli & mustard seed soup and Broccoli soup in Ileostomy - Stoma, sponsored by University of Ulster. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-03.

Sponsored by University of Ulster · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 5 months after the study started (first participant enrolled Mar 2015, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Epidemiological and experimental studies have indicated that the consumption of diets rich in cruciferous vegetables such as broccoli has a range of beneficial effects on human health. These effects are usually attributed to naturally-occurring glucosinolates and their breakdown products, isothiocyanates, in cruciferous vegetables. One of these compounds, sulforaphane, the hydrolysis product of glucoraphanin, the main glucosinolate in broccoli has been reported to have bactericidal activity against H. pylori and other human pathogens. The investigators have recently shown that adding mustard seeds, which contain a more resilient form of this enzyme, to processed broccoli actually increased the formation of sulforaphane and minimised production of another biologically-inactive form. Experimental studies by the investigators have shown that sulforaphane can inhibit growth of a number of enteric pathogens including salmonella and E. coli which exert their effects in the small intestine. Currently the bioavailability, stability and bioactivity of sulforaphane in the small intestine of a human following consumption of broccoli is not known.

To assess the effect of broccoli phytochemicals in vivo 20 participants who have previously had an ileostomy (removal of colon, > 1.5 years post operative) will be fed 200 ml of broccoli soup/control in a randomised double blind crossover design and collect the ileal fluid before (0 hr) and after (4 hr) the feeding. The ileal fluid collected from participants will have undergone in vivo digestion, allowing analysis of the chemical composition and bioactivity of the ileal fluid. The hypothesis to be tested is that consumption of cooked broccoli plus myrosinase from mustard seeds will result in high levels of sulforaphane in ileostomy fluid, sufficient to suppress growth of enteric pathogens. This study will be used to assess whether previous observations on the in vitro antibacterial activity of broccoli are relevant in vivo.

02

Conditions studied

  • Ileostomy - Stoma

Keywords

  • Broccoli
  • Bioavailability
  • Ileostomists
  • Randomised controlled trial
  • Phytochemical
03

In context

Lead sponsor

University of Ulster is the lead sponsor of 94 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • undergone an ileostomy and be more than 1.5 year post-operative
  • non smoking

Exclusion criteria

Exclusion Criteria:

  • not undergone an ileostomy and/or is less than 1.5 year post-operative
  • smoker.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Broccoli & mustard seed soup

    200ml acute feed

    Dietary Supplement: Broccoli & mustard seed soup · Dietary Supplement: Broccoli soup

  • Active comparator
    Broccoli soup

    200ml acute feed

    Dietary Supplement: Broccoli & mustard seed soup · Dietary Supplement: Broccoli soup

Interventions

  • Dietary supplementBroccoli & mustard seed soup

    200ml acute feed

  • Dietary supplementBroccoli soup

    200ml acute feed

06

What researchers measure

Primary outcomes

  1. Phytochemical concentration

    Ileal fluid analysis by Gas Chromatography Mass Spec (GCMS) and Liquid Chromatography / Mass Spec (LC/MS)

    Time frame: Change over 4 hours

Secondary outcomes

  1. Inhibition of enteric pathogens

    Ileal fluid tissue culture analysis (zone of inhibition (mm))

    Time frame: Change over 4 hours

07

Study locations

1 site
  • Human Intervention Studies Unit, Ulster University
    Coleraine, Co.Londonderry BT52 1SA, United Kingdom
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04113928
Lead sponsor
University of Ulster
Collaborators
University of Reading, The James Hutton Institute
Responsible party
Sponsor
First posted
Oct 3, 2019
Start date
Mar 23, 2015
Primary completion
Apr 3, 2015
Completion
Apr 3, 2015
Last update
Oct 3, 2019

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 Oct 2019. You cannot join it, but the record below documents what was studied.

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