Broccoli Ileo Study

NCT ID: NCT04113928

Last Updated: 2019-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-23

Study Completion Date

2015-04-03

Brief Summary

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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.

Detailed Description

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Conditions

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Ileostomy - Stoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised double blind crossover design.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators
Double blind

Study Groups

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Broccoli & mustard seed soup

200ml acute feed

Group Type EXPERIMENTAL

Broccoli & mustard seed soup

Intervention Type DIETARY_SUPPLEMENT

200ml acute feed

Broccoli soup

Intervention Type DIETARY_SUPPLEMENT

200ml acute feed

Broccoli soup

200ml acute feed

Group Type ACTIVE_COMPARATOR

Broccoli & mustard seed soup

Intervention Type DIETARY_SUPPLEMENT

200ml acute feed

Broccoli soup

Intervention Type DIETARY_SUPPLEMENT

200ml acute feed

Interventions

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Broccoli & mustard seed soup

200ml acute feed

Intervention Type DIETARY_SUPPLEMENT

Broccoli soup

200ml acute feed

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* not undergone an ileostomy and/or is less than 1.5 year post-operative
* smoker.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role collaborator

The James Hutton Institute

UNKNOWN

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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14/SC/1326

Identifier Type: -

Identifier Source: org_study_id

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