Broccoli Ileo Study

Maximising the Bioavailability and Activity of Broccoli Phytochemicals Using a Broccoli Soup Enriched for Myrosinase by Addition of Mustard Seeds

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.

Study Overview

• Status: Completed
• Conditions: Ileostomy - Stoma
• Intervention / Treatment: Dietary supplement: Broccoli & mustard seed soup; Dietary supplement: Broccoli soup

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Broccoli & mustard seed soup; 200ml acute feed	Dietary supplement: Broccoli & mustard seed soup; 200ml acute feed; Dietary supplement: Broccoli soup; 200ml acute feed
Active Comparator: Broccoli soup; 200ml acute feed	Dietary supplement: Broccoli & mustard seed soup; 200ml acute feed; Dietary supplement: Broccoli soup; 200ml acute feed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phytochemical concentration	Ileal fluid analysis by Gas Chromatography Mass Spec (GCMS) and Liquid Chromatography / Mass Spec (LC/MS)	Change over 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inhibition of enteric pathogens	Ileal fluid tissue culture analysis (zone of inhibition (mm))	Change over 4 hours

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: University of Reading; The James Hutton Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2015
• Primary Completion (Actual): April 3, 2015
• Study Completion (Actual): April 3, 2015

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Bioavailability; Phytochemical; Ileostomists; Broccoli
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Mechlorethamine
• Other Study ID Numbers: 14/SC/1326

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No