Ileostomy - StomaNCT03765606
Cocoa Ileostomy Study
A study testing Cocoa Flavanol beverage mix and De-xanthinated Cocoa Flavanol beverage mix in people with Ileostomy - Stoma, run by University of Ulster at 1 site in United Kingdom.
Trial summary
There is substantial interest in the potential role of chocolate and its primary bioactive component; flavan-3-ol, (-)-epicatechin, in both the prevention and management of cardiovascular disease (CVD). 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?
- Cocoa Flavanol beverage mix and De-xanthinated Cocoa Flavanol beverage mix
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Apr 2018to 4 May 2018
- 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-years post-operative
- Male or female
- Aged between 18-65 years
- Non-smoking
- Not lactose/milk/dairy intolerant
Who cannot join
- Has not undergone an ileostomy and/or is less than 1.5 year post-operative
- Pregnant/ lactating females
- Smokers
- Lactose/milk/diary intolerant
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: The Bioavailability of Cocoa Flavan-3-ols and Interaction With the Methylxanthine, Theobromine: a Study With Ileostomists
There is substantial interest in the potential role of chocolate and its primary bioactive component; flavan-3-ol, (-)-epicatechin, in both the prevention and management of cardiovascular disease (CVD). Numerous observational studies have found the association between high cocoa intake and a reduced CVD risk and mortality, yet the impact of these mechanisms in vivo is unclear. In order to have a beneficial effect, these cocoa flavan-3-ols must be absorbed in the body in a forms, while still maintaining its advantageous characteristics. Consumption studies with ileostomists who have had their colon removed,provide information regarding the bioavailability and bioactivity of (-)-epicatechin and flavan-3-ols from cocoa, therefore the aim of this study is to determine the impact of methylaxanthines (including theobromine) on bioavailability of cocoa flavan-3-ols prior to entering the colon.
This study has a randomised double blinded crossover control design, being applied to ileostomy patients who are aged 18-65 years, N=10, 5 per group. The study is divided into two phases. During the first phase, subjects will partake in a 2-day restriction diet (No phenolic foods) and an overnight fast prior to sampling. Ileal fluid (0hr) is obtained from participants. They will then be asked to consume the cocoa flavanol beverage dissolved in 310g 1% milk. After this urine and ieal fluid is collected every 4 hours at 3 more time points and blood every hour at 8 time points. A 24 hr urine and ieal fluid sample is collected the following day. There will be a 1-week wash out period between each phase. Procedure is repeated again for phase 2.
- Conditions
- Ileostomy - Stoma
- Being tested
- Cocoa Flavanol beverage mix, De-xanthinated Cocoa Flavanol beverage mix
- Keywords
- Cocoa Flavan-3-ols, methylaxanthin, theobromine, Ileostomists, bioavailability, randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cocoa Flavanol beverage mixDietary supplement
Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.
De-xanthinated Cocoa Flavanol beverage mixDietary supplement
Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.
| Study group | Role | What they receive |
|---|---|---|
| Cocoa Flavanol beverage mix | Placebo comparator | Cocoa Flavanol beverage mix (flavanols, 566mg; caffeine, 11mg \& theobromine, 93mg) Receives: Dietary Supplement: Cocoa Flavanol beverage mix |
| De-xanthinated Cocoa Flavanol beverage mix | Experimental | De-xanthinated Cocoa Flavanol beverage mix (flavanols, 583mg; caffeine, 0.6mg \& theobromine, 0.2mg) Receives: Dietary Supplement: De-xanthinated Cocoa Flavanol beverage mix |
What is being measured
The primary outcome is the main question the study is designed to answer.
cocoa flavan-3-ols bio-availability
Recovery of ingested flavan-3-ols in ileal fluid
Measured: 24-hour period post-consumption
cocoa flavan-3-ols bio-availability
Uptake of ingested flavan-3-ols in plasma
Measured: Change over 8-hour period post-consumption
cocoa flavan-3-ols availability
Recovery of ingested flavan-3-ols in urine
Measured: Change over 24-hour period post-consumption
Secondary outcomes (1)
Simulated gut microbiota
Ileal fluid with/without simulated colonic fermentation
Measured: Change over 24-hour in vitro fermentation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start9 Apr 2018
- Primary completion4 May 2018
- Study completion4 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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-blinded crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765606
- Sponsor's protocol ID
- UREC/18/0007
- Status last verified
- Jun 2018
- First submitted
- 4 Dec 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ottaviani JI, Fong RY, Borges G, Kimball J, Ensunsa JL, Medici V, Pourshahidi LK, Kane E, Ward K, Durkan R, Dobani S, Lawther R, O'Connor G, Gill CIR, Schroeter H, Crozier A. Flavan-3-ol-methylxanthine interactions: Modulation of flavan-3-ol bioavailability in volunteers with a functional colon and an ileostomy. Free Radic Biol Med. 2023 Feb 20;196:1-8. doi: 10.1016/j.freeradbiomed.2023.01.003. Epub 2023 Jan 5.
PubMed 36621554
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Bioavailability of Cocoa Flavan-3-ols and Interaction With the Methylxanthine, Theobromine: a Study With Ileostomists
- ClinicalTrials.gov ID
- NCT03765606
- Acronym / sponsor ID
- UREC/18/0007
- Conditions
- Ileostomy - Stoma
- Keywords
- Cocoa Flavan-3-ols, methylaxanthin, theobromine, Ileostomists, bioavailability, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 4 May 2018 (actual)
- Study completion
- 4 May 2018 (actual)
- First posted
- 5 Dec 2018 (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.
There is substantial interest in the potential role of chocolate and its primary bioactive component; flavan-3-ol, (-)-epicatechin, in both the prevention and management of cardiovascular disease (CVD). Numerous observational studies have found the association between high cocoa intake and a reduced CVD risk and mortality, yet the impact of these mechanisms in vivo is unclear. In order to have a beneficial effect, these cocoa flavan-3-ols must be absorbed in the body in a forms, while still maintaining its advantageous characteristics. Consumption studies with ileostomists who have had their colon removed,provide information regarding the bioavailability and bioactivity of (-)-epicatechin and flavan-3-ols from cocoa, therefore the aim of this study is to determine the impact of methylaxanthines (including theobromine) on bioavailability of cocoa flavan-3-ols prior to entering the colon.
This study has a randomised double blinded crossover control design, being applied to ileostomy patients who are aged 18-65 years, N=10, 5 per group. The study is divided into two phases. During the first phase, subjects will partake in a 2-day restriction diet (No phenolic foods) and an overnight fast prior to sampling. Ileal fluid (0hr) is obtained from participants. They will then be asked to consume the cocoa flavanol beverage dissolved in 310g 1% milk. After this urine and ieal fluid is collected every 4 hours at 3 more time points and blood every hour at 8 time points. A 24 hr urine and ieal fluid sample is collected the following day. There will be a 1-week wash out period between each phase. Procedure is repeated again for phase 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised double-blinded crossover
| Arm | Type | Receives |
|---|---|---|
| Cocoa Flavanol beverage mix | Placebo comparator | Dietary Supplement: Cocoa Flavanol beverage mixCocoa Flavanol beverage mix (flavanols, 566mg; caffeine, 11mg \& theobromine, 93mg) |
| De-xanthinated Cocoa Flavanol beverage mix | Experimental | Dietary Supplement: De-xanthinated Cocoa Flavanol beverage mixDe-xanthinated Cocoa Flavanol beverage mix (flavanols, 583mg; caffeine, 0.6mg \& theobromine, 0.2mg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Undergone an ileostomy and be more than 1.5-years post-operative
- Male or female
- Aged between 18-65 years
- Non-smoking
- Not lactose/milk/dairy intolerant
Key exclusion criteria (4 listed)
- Has not undergone an ileostomy and/or is less than 1.5 year post-operative
- Pregnant/ lactating females
- Smokers
- Lactose/milk/diary intolerant
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 |
|---|---|---|
| Cocoa Flavanol beverage mixAcute consumption of single portion of cocoa powder dissolved in 310g 1% milk. | Dietary supplement | Cocoa Flavanol beverage mix |
| De-xanthinated Cocoa Flavanol beverage mixAcute consumption of single portion of cocoa powder dissolved in 310g 1% milk. | Dietary supplement | De-xanthinated Cocoa Flavanol beverage mix |
Primary outcome
cocoa flavan-3-ols bio-availability
Time frame: 24-hour period post-consumption
Recovery of ingested flavan-3-ols in ileal fluid
cocoa flavan-3-ols bio-availability
Time frame: Change over 8-hour period post-consumption
Uptake of ingested flavan-3-ols in plasma
cocoa flavan-3-ols availability
Time frame: Change over 24-hour period post-consumption
Recovery of ingested flavan-3-ols in urine
1 secondary outcome
Simulated gut microbiota
Time frame: Change over 24-hour in vitro fermentation period
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 5 Dec 2018.
- Derived from this study: PubMed 36621554Ottaviani JI, Fong RY, Borges G, Kimball J, Ensunsa JL, Medici V, Pourshahidi LK, Kane E, Ward K, Durkan R, Dobani S, Lawther R, O'Connor G, Gill CIR, Schroeter H, Crozier A. Flavan-3-ol-methylxanthine interactions: Modulation of flavan-3-ol bioavailability in volunteers with a functional colon and an ileostomy. Free Radic Biol Med. 2023 Feb 20;196:1-8. doi: 10.1016/j.freeradbiomed.2023.01.003. Epub 2023 Jan 5.
- 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 Cocoa Flavanol beverage mix and De-xanthinated Cocoa Flavanol beverage mix 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 5 inclusion and 4 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 5 Dec 2018. 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. Some participants in this study may receive a placebo. 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?
cocoa flavan-3-ols bio-availability (time frame: 24-hour period post-consumption). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765606, which also lists 1 linked publication.
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 5 Dec 2018.