Bioavailability and Bioactivity of Orange Polyphenols (NCT06430138) | Clinical Trial Compass
CompletedNot Applicable
Bioavailability and Bioactivity of Orange Polyphenols
United Kingdom20 participantsStarted 2024-04-26
Plain-language summary
This study will provide a greater insight into the relationship between orange consumption and health (particularly gut health) and could be used to help with the development of novel food products. Oranges are a rich source of (poly)phenols, and although the advantages of a (poly)phenol-rich diet are well-established, the bioavailability and bioactivity of orange (poly)phenols in the context of human digestion are poorly understood. This study will address this gap in research.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria: (ileostomates)
* Adult with an ileostomy, ≥1.5-years post-operative
* Aged 18-75 years at recruitment
* Not pregnant / lactating
* No learning or other disabilities
* Not currently taking antibiotics
* Not currently taking plant-based dietary supplements
* Not currently taking any prescribed medications that would prevent overnight fasting
Inclusion Criteria Healthy adults; no pre-existing chronic disease (GI related)
* Aged 18-75 years at recruitment
* Not pregnant / lactating
* No learning or other disabilities
* Not currently taking antibiotics
* Not currently taking plant-based dietary supplements
* Not currently taking any prescribed medications that would prevent overnight fasting
Exclusion criteria (Ileostomates):
* Adults \<18 or \>75 years at recruitment
* Ileostomy, \<1.5 years post-operative
* Pregnant/lactating females
* Adults with learning or other disabilities
* Citrus fruit (orange) allergy or sensitivity
* Currently taking antibiotics
* Currently taking plant-based dietary supplements
* Currently taking any prescribed medications that would prevent overnight fasting
Exclusion criteria (Healthy adults):
* Adults \<18 or \>70 years at recruitment
* Pregnant/lactating females
* Adults with learning or other disabilities
* Citrus fruit (orange) allergy or sensitivity
* Currently taking antibiotics
* Currently taking plant-based dietary supplements
* Currently taking any prescribed medications that would prevent overnight fasting
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quantification of circulating (blood) (poly)phenols and microbially derived metabolites in participants with colon compared to without colon (ileostomates).
Timeframe: Change over 24 hours compared
2
Quantification of urinary (poly)phenols and microbially derived metabolites in participants with colon compared to without colon (ileostomates).