Understanding (Poly)Phenol Metabolism in People With an Ileostomy
ConditionIleostomy - Stoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Ulster
About this trial
Plant foods contain natural compounds called (poly)phenols, which may help lower the risk of heart and metabolic diseases. However, people differ greatly in how they absorb and process these compounds, partly because most (poly)phenols are broken down by gut bacteria in the colon. This makes it difficult to know exactly which metabolites come from the diet, and which are produced by the body. Studying people with an ileostomy provides a unique opportunity to understand how much is absorbed in the small intestine and how these compounds are transformed. This will help us better understand individual responses to dietary (poly)phenols.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Currently living with an ileostomy
> 1-year post-operative
Aged 18 - 75 years
BMI 18 - 28 kg/m2
Disqualifiers
Not currently living with an ileostomy
Ileostomy formed < 1 year previously
Not aged 18 - 75 years
BMI <18 or >28 kg/m2
Trial design
Design model
Single group
Treatments tested in this trial
(Poly)phenol rich capsules
Dietary supplement(Poly)phenol rich capsules (\~3 g)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: (Poly)phenol rich capsulesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Variability of phenolic metabolites in ileal fluid
The primary objective will be assessment of the variability in the ileal concentration of phenolic metabolites among individuals and the potential grouping of the individuals into metabotypes after acute (poly)phenol consumption.
Time frame
From enrolment to the end of treatment at 1 week.Secondary outcomes
1
Identification and quantification of low molecular weight phenolics
Identify and quantify the low molecular weight phenolics (LMWP) in biological samples (urine, ileal fluid) in a low-(poly)phenol controlled diet context, before and after the intake of (poly)phenol-rich capsules, therefore allowing for assessment of the ratio of exogenous/endogenous sources of LMWP.
Time frame
From enrolment to end of treatment at 1 week.2
Influence of macronutrients over low molecular weight phenolic production
Evaluate the influence of macronutrients over LMWP production considering the subject's microbiota profiles and single nucleotide polymorphisms (SNPs).
Time frame
From enrolment to end of treatment at 1 week.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Ulster
Lead sponsor
University of Parma
Collaborator
Source ClinicalTrials.gov