NCT07772362

Brief Summary

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.

Trial Health

77
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
19mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Aug 2026May 2028

Study Start

First participant enrolled

August 1, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

August 19, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

August 13, 2026

Last Update Submit

August 13, 2026

Conditions

Ileostomy - Stoma

Keywords

Ileostomy(Poly)phenolBioavailabilityMetabolismLow molecular weight phenolics

Outcome Measures

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.

    From enrolment to the end of treatment at 1 week.

Secondary Outcomes (2)

  • Identification and quantification of low molecular weight phenolics

    From enrolment to end of treatment at 1 week.

  • Influence of macronutrients over low molecular weight phenolic production

    From enrolment to end of treatment at 1 week.

Study Arms (1)

(Poly)phenol rich capsules

EXPERIMENTAL

(Poly)phenol rich capsules (\~3 g)

Dietary Supplement: (Poly)phenol rich capsules

Interventions

(Poly)phenol rich capsulesDIETARY_SUPPLEMENT

(Poly)phenol rich capsules (\~3 g)

(Poly)phenol rich capsules

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently living with an ileostomy
  • \> 1-year post-operative
  • Aged 18 - 75 years
  • BMI 18 - 28 kg/m2
  • Males and females (not currently pregnant / lactating)
  • Non-smokers (including vaping)
  • Not taking antibiotic therapy 3 months prior to the study
  • No phytochemical supplement usage 2 weeks prior to study start.
  • Free-living (i.e. not housebound)
  • No participation in other biomedical studies 3 months prior.

You may not qualify if:

  • Not currently living with an ileostomy
  • Ileostomy formed \< 1 year previously
  • Not aged 18 - 75 years
  • BMI \<18 or \>28 kg/m2
  • Pregnant / lactating female
  • Smokers (including vaping)
  • Those taking antibiotic therapy 3 months prior to the study
  • Phytochemical supplement usage within 2 weeks of study start.
  • Housebound or otherwise unable to attend testing visits.
  • Participation in a biomedical study (3 months prior to study start).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry, BT521SA

Coleraine, United Kingdom

RECRUITING

Related Publications (2)

  • P. Mena, C. Mignogna, N. Tosi, E. Monica, V. Agulló, A. Rosi, L. Narduzzi, V. Spigoni, R. Aldigeri, A. Bianchera, L. Bresciani, E. Balestreri, E. Eletto, G. Frigeri, R. Musa, P. Cerati, R. Aloe, D. Martorana, A. Gil-Izquierdo, A.-M. Minihane, F. Scazzina, R. Bettini, F. Brighenti, M. Ventura, A. Acharjee, A. Dei Cas, R. Bonadonna and D. Del Rio, Development of an Oral (Poly)Phenol Challenge Test (OPCT) to Identify Aggregate Metabotypes for Dietary (Poly)Phenols and Their Drivers: A Study Protocol, Current Developments in Nutrition, 2022, 6 (Suppl. 1), 1148, DOI 10.1093/cdn/nzac072.020

    BACKGROUND

  • Zeraik L, Rosi A, Del Rio D, Crozier A, Bresciani L, Mena P. Endogenous and/or exogenous origin of phenolic metabolites in humans (the ENDOPHENOL project): study protocol for a randomized, controlled, crossover trial. Trials. 2025 Dec 19;26(1):571. doi: 10.1186/s13063-025-09215-9.

    PMID: 41420184BACKGROUND

Central Study Contacts

Chris IR Gill, PhD

CONTACT

+44 28 7012 3181c.gill@ulster.ac.uk

Ruth Price, PhD

CONTACT

+442870123878rk.price@ulster.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single arm acute feeding study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2026

First Posted

August 19, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

August 19, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)