NCT04113928

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2015

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2015

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 3, 2019

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

11 days

First QC Date

September 17, 2019

Last Update Submit

October 1, 2019

Conditions

Ileostomy - Stoma

Keywords

BroccoliBioavailabilityIleostomistsRandomised controlled trialPhytochemical

Outcome Measures

Primary Outcomes (1)

  • Phytochemical concentration

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

    Change over 4 hours

Secondary Outcomes (1)

  • Inhibition of enteric pathogens

    Change over 4 hours

Study Arms (2)

Broccoli & mustard seed soup

EXPERIMENTAL

200ml acute feed

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

Broccoli soup

ACTIVE COMPARATOR

200ml acute feed

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

Interventions

Broccoli & mustard seed soupDIETARY_SUPPLEMENT

200ml acute feed

Broccoli & mustard seed soupBroccoli soup
Broccoli soupDIETARY_SUPPLEMENT

200ml acute feed

Broccoli & mustard seed soupBroccoli soup

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blind
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomised double blind crossover design.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2019

First Posted

October 3, 2019

Study Start

March 23, 2015

Primary Completion

April 3, 2015

Study Completion

April 3, 2015

Last Updated

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)