Ileostomy - StomaNCT04113928
Broccoli Ileo Study
A study testing Broccoli & mustard seed soup and Broccoli soup in people with Ileostomy - Stoma, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- Broccoli & mustard seed soup and Broccoli soup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2015to 3 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- undergone an ileostomy and be more than 1.5 year post-operative
- non smoking
Who cannot join
- not undergone an ileostomy and/or is less than 1.5 year post-operative
- smoker.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA
About this study
Official title: 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.
- Conditions
- Ileostomy - Stoma
- Being tested
- Broccoli & mustard seed soup, Broccoli soup
- Keywords
- Broccoli, Bioavailability, Ileostomists, Randomised controlled trial, Phytochemical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broccoli & mustard seed soupDietary supplement
200ml acute feed
Broccoli soupDietary supplement
200ml acute feed
| Study group | Role | What they receive |
|---|---|---|
| Broccoli & mustard seed soup | Experimental | 200ml acute feed Receives: Dietary Supplement: Broccoli & mustard seed soup; Dietary Supplement: Broccoli soup |
| Broccoli soup | Active comparator | 200ml acute feed Receives: Dietary Supplement: Broccoli & mustard seed soup; Dietary Supplement: Broccoli soup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phytochemical concentration
Ileal fluid analysis by Gas Chromatography Mass Spec (GCMS) and Liquid Chromatography / Mass Spec (LC/MS)
Measured: Change over 4 hours
Secondary outcomes (1)
Inhibition of enteric pathogens
Ileal fluid tissue culture analysis (zone of inhibition (mm))
Measured: Change over 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start23 Mar 2015
- Primary completion3 Apr 2015
- Study completion3 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy - StomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomised double blind crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading, The James Hutton Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113928
- Sponsor's protocol ID
- 14/SC/1326
- Status last verified
- Oct 2019
- First submitted
- 17 Sep 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximising the Bioavailability and Activity of Broccoli Phytochemicals Using a Broccoli Soup Enriched for Myrosinase by Addition of Mustard Seeds
- ClinicalTrials.gov ID
- NCT04113928
- Acronym / sponsor ID
- 14/SC/1326
- Conditions
- Ileostomy - Stoma
- Keywords
- Broccoli, Bioavailability, Ileostomists, Randomised controlled trial, Phytochemical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University of Reading, The James Hutton Institute
- Study start
- 23 Mar 2015 (actual)
- Primary completion
- 3 Apr 2015 (actual)
- Study completion
- 3 Apr 2015 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomised double blind crossover design.
| Arm | Type | Receives |
|---|---|---|
| Broccoli & mustard seed soup | Experimental | Dietary Supplement: Broccoli & mustard seed soup, Dietary Supplement: Broccoli soup200ml acute feed |
| Broccoli soup | Active comparator | Dietary Supplement: Broccoli & mustard seed soup, Dietary Supplement: Broccoli soup200ml acute feed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- undergone an ileostomy and be more than 1.5 year post-operative
- non smoking
Key exclusion criteria (2 listed)
- not undergone an ileostomy and/or is less than 1.5 year post-operative
- smoker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broccoli & mustard seed soup200ml acute feed | Dietary supplement | Broccoli & mustard seed soup, Broccoli soup |
| Broccoli soup200ml acute feed | Dietary supplement | Broccoli & mustard seed soup, Broccoli soup |
Primary outcome
Phytochemical concentration
Time frame: Change over 4 hours
Ileal fluid analysis by Gas Chromatography Mass Spec (GCMS) and Liquid Chromatography / Mass Spec (LC/MS)
1 secondary outcome
Inhibition of enteric pathogens
Time frame: Change over 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Broccoli & mustard seed soup and Broccoli soup in people with Ileostomy - Stoma, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phytochemical concentration (time frame: Change over 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.