Bioavailability and Bioactivity of Orange Polyphenols

NCT06430138 | Recruiting

• 1 other identifier: REC/24/0002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Nutrition

Keywords

Orange,; polyphenols; ileostomy

Outcome Measures

Primary Outcomes (2)

• Quantification of circulating (blood) (poly)phenols and microbially derived metabolites in participants with colon compared to without colon (ileostomates).

  Quantification of polyphenols via LC-MS/MS

  Change over 24 hours compared

• Quantification of urinary (poly)phenols and microbially derived metabolites in participants with colon compared to without colon (ileostomates).

  Quantification of polyphenols via LC-MS/MS

  Change over 24 hours ]

Secondary Outcomes (2)

• ileal fluid polyphenolic metabolites.

  Change over 24 hours

• Ileal fluid microbial mediated metabolites

  Change over 24 hours

Study Arms (2)

Healthy participants

EXPERIMENTAL

Participant will be given Orange Juice 300ml to drink

Dietary Supplement: 300ml Orange Juice

Ileostomy participants

ACTIVE COMPARATOR

Participant will be given orange Juice 300ml to drink

Dietary Supplement: 300ml Orange Juice

Interventions

300ml Orange Juice DIETARY_SUPPLEMENT

Acute intervention in populations with and without colon

Healthy participants; Ileostomy participants

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Ulster: lead
• Andalusian Institute of Agricultural and Fisheries Research and Training (IFAPA): collaborator

Study Sites (1)

Ulster University,Human Intervention Studies Unit,

Coleraine, Co. Londonderry, BT521SA, United Kingdom

RECRUITING

Central Study Contacts

Prof Gill, PhD

CONTACT

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

Ruth Price, PhD

CONTACT

+442870123878; rk.price@ulster.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single Blind(with masked participant)
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Acute intervention in populations with and without colon

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 28, 2024
• Study Start: April 26, 2024
• Primary Completion: September 13, 2024
• Study Completion: December 13, 2024
• Last Updated: May 28, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)