Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430138
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2024-04-23
Brief Title:
Bioavailability and Bioactivity of Orange Polyphenols
Sponsor:
University of Ulster
Organization:
University of Ulster
Study Overview
Official Title:
Bioavailability and Bioactivity of Orange Polyphenols on Gut Health
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORANGUT
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 polyphenols and although the advantages of a polyphenol-rich diet are well-established the bioavailability and bioactivity of orange polyphenols in the context of human digestion are poorly understood This study will address this gap in research
Detailed Description:
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 polyphenols and although the advantages of a polyphenol-rich diet are well-established the bioavailability and bioactivity of orange polyphenols 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 groups 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 polyphenols The participants will be provided with a restriction low polyphenol meal which they will consume the evening before the study at approximately 6 - 700pm 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 polyphenol 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 N20 will provide 10 blood samples and 3 urine samples over the study period
Blood samples
Upon arrival at the HISU a qualified phlebotomist will fit a cannula and collect a blood sample 0hr 8ml The participant will then be given the intervention 300 ml of orange juice A further 8 blood samples will be collected at 1hr intervals 1hr 2hr 3hr 4hr 5hr 6hr 7hr 8hr After the 8hr blood draw the cannula will be removed by the phlebotomist and the participant will be free to go home They will return to the HISU the following morning to provide a final blood sample 24hr Ten blood samples will be collected in total
Urine samples
Participants will start a 24-hour urine collection the day before the study day They will be provided with a 2L urine container in advance of commencing the urine collection participants will use this to deposit urine samples over the 24-hr period Upon arrival at the HISU on the morning of the study participants will return the urine container holding the -24 to 0 hr urine sample Participants will complete two additional urine collections 0-8hr and 8-24hr samples a fresh urine container will be provided at each time point The 8-24hr sample will be returned by the participant when they return to the HISU to provide the 24hr blood sample
Ileostomist participants n10 will also provide three ileal samples over the study period
Ileal samples
Participants will be asked to refrain from emptying their stoma bag upon waking on the morning of the study Upon arrival at the HISU an ileal sample will be collected the overnight stoma bag will be removed and replaced with a new stoma bag by the participant Two additional ileal samples will be collected at 0-8 hr and 8-24 hrs the stoma bag will be removed and replaced with a new stoma bag by the participant at each sampling point The 8-24hr sample will be returned by the participant when they return to the HISU to provide the 24hr blood sample Multiple stoma bags may be used by the participant as required
Height and weight measurements will also be taken for all participants N20 during their visit to the HISU
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 groups 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 polyphenols The participants will be provided with a restriction low polyphenol meal which they will consume the evening before the study at approximately 6 - 700pm 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 polyphenol 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 N20 will provide 10 blood samples and 3 urine samples over the study period
Blood samples
Upon arrival at the HISU a qualified phlebotomist will fit a cannula and collect a blood sample 0hr 8ml The participant will then be given the intervention 300 ml of orange juice A further 8 blood samples will be collected at 1hr intervals 1hr 2hr 3hr 4hr 5hr 6hr 7hr 8hr After the 8hr blood draw the cannula will be removed by the phlebotomist and the participant will be free to go home They will return to the HISU the following morning to provide a final blood sample 24hr Ten blood samples will be collected in total
Urine samples
Participants will start a 24-hour urine collection the day before the study day They will be provided with a 2L urine container in advance of commencing the urine collection participants will use this to deposit urine samples over the 24-hr period Upon arrival at the HISU on the morning of the study participants will return the urine container holding the -24 to 0 hr urine sample Participants will complete two additional urine collections 0-8hr and 8-24hr samples a fresh urine container will be provided at each time point The 8-24hr sample will be returned by the participant when they return to the HISU to provide the 24hr blood sample
Ileostomist participants n10 will also provide three ileal samples over the study period
Ileal samples
Participants will be asked to refrain from emptying their stoma bag upon waking on the morning of the study Upon arrival at the HISU an ileal sample will be collected the overnight stoma bag will be removed and replaced with a new stoma bag by the participant Two additional ileal samples will be collected at 0-8 hr and 8-24 hrs the stoma bag will be removed and replaced with a new stoma bag by the participant at each sampling point The 8-24hr sample will be returned by the participant when they return to the HISU to provide the 24hr blood sample Multiple stoma bags may be used by the participant as required
Height and weight measurements will also be taken for all participants N20 during their visit to the HISU
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None