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临床试验/NCT06430138
NCT06430138已完成不适用

Bioavailability and Bioactivity of Orange Polyphenols on Gut Health

University of Ulster2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年4月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Quantification of circulating (blood) (poly)phenols and microbially derived metabolites in participants with colon compared to without colon (ileostomates).

研究概览

简要总结

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.

详细描述

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.

Until recently, analysis of biofluids with HPLC-MS revealed relatively simple phenolic profiles. However, with current high resolution (HR)-MS instrumentation detection limits and selectivity have improved greatly and HPLC-HR-MS methodology is now the analytical method of choice. Consequently, the number of phenolics that can be monitored has increased markedly in recent years. A previous study, using validated methodology, identified 65 phenolic compounds in urine collected after ingestion of orange juice.

In the proposed project it is planned to use such analytical methodology for targeted and untargeted metabolomics of flavanone metabolites and colonic catabolites in biofluids collected after consumption of orange juice by ileostomists and subjects with a functioning colon. Metabolomics refers to the measurement of metabolites present within a cell, tissue, or organism resulting from physiological stimulus - in the context of the current study, the stimulus is orange juice consumption. Untargeted metabolomics involves a comprehensive analysis of all measurable substances in a sample of unknown metabolites, and targeted metabolomics denotes the quantification of defined group(s) of metabolites. The particular value of including ileostomists in the study is that analysis of their ileal fluid and urine will provide valuable information on compounds derived from the ingested OJ flavanones, prior to digestion and absorption by the large intestine.

Acute bioavailability feeding study in two groups; ileostomists and healthy adults. The study will take place in the Human Intervention Studies Unit (HISU), at Ulster University, Coleraine Campus. Prior to attending the HISU, participants will be asked to follow a restriction diet for 72 hours before the study and the 24 hours of the study day, which will involve the intake of food containing low levels of (poly)phenols. The participants will be provided with a restriction (low (poly)phenol) meal, which they will consume the evening before the study (at approximately 6 - 7.00pm) and fast until attending the HISU the following morning. This means no food will be taken overnight and no breakfast taken prior to attending the HISU.

Low (poly)phenol foods will be provided to participants on the day of the study, and they will be asked to continue this restriction diet until all samples have been collected. Healthy participants and Ileostomists (N=20) will provide 10 blood samples and 3 urine samples over the study period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Single Blind(with masked participant)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (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

排除标准

  • (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

研究组 & 干预措施

Healthy participants

Experimental

Participant will be given Orange Juice 300ml to drink

干预措施: 300ml Orange Juice (Dietary Supplement)

Ileostomy participants

Active Comparator

Participant will be given orange Juice 300ml to drink

干预措施: 300ml Orange Juice (Dietary Supplement)

结局指标

主要结局

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

时间窗: Change over 24 hours compared

Quantification of polyphenols via LC-MS/MS

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

时间窗: Change over 24 hours ]

Quantification of polyphenols via LC-MS/MS

次要结局

  • ileal fluid polyphenolic metabolites.(Change over 24 hours)
  • Ileal fluid microbial mediated metabolites(Change over 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Bioavailability and Bioactivity of Orange Polyphenols | 临床试验