Broccoli Ileo Study

NCT04113928 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-10-03

No results posted yet for this 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.

Conditions

  • Ileostomy - Stoma

Interventions

DIETARY_SUPPLEMENT

Broccoli & mustard seed soup

200ml acute feed

DIETARY_SUPPLEMENT

Broccoli soup

200ml acute feed

Sponsors & Collaborators

  • University of Reading

    collaborator OTHER
  • The James Hutton Institute

    collaborator UNKNOWN
  • University of Ulster

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-23
Primary Completion
2015-04-03
Completion
2015-04-03

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04113928 on ClinicalTrials.gov