Understanding how orange polyphenols affect gut health
Bioavailability and Bioactivity of Orange Polyphenols on Gut Health
This study is testing how eating oranges affects gut health by looking at how the body processes compounds from orange juice in both healthy people and those with ileostomies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Ulster Academic / other |
| Locations | 1 site (Coleraine, Co. Londonderry) |
| Trial ID | NCT06430138 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between orange consumption and gut health, focusing on the bioavailability and bioactivity of orange polyphenols. By utilizing advanced analytical methods like HPLC-HR-MS, the study aims to analyze metabolites in biofluids from participants after consuming orange juice. The research will include both ileostomates and healthy adults to provide insights into how these compounds are processed in the human body. The findings could contribute to the development of new food products that leverage the health benefits of oranges.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with an ileostomy who are at least 1.5 years post-operative.
Not a fit: Patients under 18 or over 75 years old, or those with citrus allergies, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of gut health and lead to improved dietary recommendations or food products rich in beneficial polyphenols.
How similar studies have performed: While studies on polyphenols have shown benefits, this specific approach focusing on orange polyphenols and ileostomy patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Coleraine, Co. Londonderry
- Ulster University,Human Intervention Studies Unit, — Coleraine, Co. Londonderry, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Prof Gill, PhD
- Email: c.gill@ulster.ac.uk
- Phone: +44 28 7012 3181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.