Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06182540
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2023-11-03
Brief Title:
Bioavailability and Bioactivity of Mango Polyphenols
Sponsor:
University of Ulster
Organization:
University of Ulster
Study Overview
Official Title:
Bioavailability and Bioactivity of Mango PolyPhenols on Gut Health
Status:
COMPLETED
Status Verified Date:
2023-11
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:
MANGUT
Brief Summary:
To date however the majority of information on bioaccessibility and bioavailability of mango phytochemicals has been generated in vitro and animal models using isolated compounds or extracts from mango leaf and mango seed kernels which do not represent the deliveryabsorption of phytochemicals from a complex food matrix such as mango puree Consequently a paucity of data exists on the bioavailability and metabolism of polyphenolic compounds following ingestion of fresh mango puree either using targeted or untargeted metabolomics approaches Mango puree polyphenolic bioavailability in humans both healthy and ilesotomists will be investigated using both targeted and untargeted metabolomics further we will establish the bioactivity of mango polyphenols with respect to gastrointestinal health A comprehensive understanding of the bioavailability of fresh mango puree polyphenols will have direct relevance to the development of any mango-based novel food products
Acute bioavailability feeding study in two groups Ileostomists n 10 and health adults N10 as described below Prior to attending the visit participants were asked to follow a restriction diet for 48 hours before the study and also during the 24 hours of the study clinic visit which involved the intake of food containing low levels of polyphenols
Ileostomists n10 Twenty four hours before clinic visit the participant started a urine collection and were asked to fast from 9pm the night before the visit ie no food taken overnight and no breakfast On the morning of the study day the participants were asked to attend the clinic bringing their overnight stoma bag The 24 hr urine sample was provided and the overnight stoma bag was removed and replaced with a new stoma bag by the participant and passed to the researcher A cannula was fitted in the participants arm by a qualified phlebotomist and a blood sample 14 ml 6 ml draw off 8ml sample collected The participant was given 300 g of mango purée to consume Blood samples 14 ml 6 ml draw off 8ml sample were collected at hourly intervals for 8 hrs from the cannula 0 0511523468 and 24 hrs Urine was collected between 0-4 hrs 4-8hrs and 8-24 hrs a fresh sample bottle was provided at each time point Ileal samples were collected at 0-4 hrs 4-8hrs and 8-24 hrs the stoma bag was removed and replaced with a new stoma bag by the participant at each sampling point A restriction diet lunch was provided to the participant after the 4 hr blood draw After the 8 hr sample the participant was free to return home The next morning the participant returned to the clinic and the 24 hr samples blood urine ileal collected The urine ileal samples were collected and normal a normal phlebotomy draw will be used to collect the 24 hr blood sample The participant is then finished the study was free to return to their normal diet
Ileostomist participants each provided 4 ileal fluid samples 4 urine samples and 10 blood samples over the sampling period
Healthy participants n10 Twenty four hours before clinic visit the participant started a urine collection they were asked to fast from 9pm the night before the visit ie no food taken overnight and no breakfast On the morning of the study day the participant was asked to attend the clinic The 24 hr urine sample was collected and a faecal sample was provided A cannula was fitted in the participants arm by a qualified phlebotomist and a blood sample 14 ml 6 ml draw off 8ml sample collected The participant was then given 300 g of mango purée to consume Blood samples 14 ml 6 ml draw off 8ml sample were collected at hourly intervals for 8 hrs from the cannula 0 0511523468 and 24 hrs Urine samples were collected between 0-4 hrs 4-8hrs and 8-24 hrs a fresh sample bottle was provided at each time point A restriction diet lunch was provided to the participant after the 4 hr blood draw After the 8 hr sample the participant was free to return home The next morning the participant returned to the clinic and the 24 hr samples blood urine faecal collected The urine and faecal samples were collected and normal a normal phlebotomy draw was used to collect the 24 hr blood sample The participant then finished the study and was free to return to their normal diet
Healthy adult participants each provided in total 2 faecal samples 4 urine samples and 10 blood samples over the sampling period
Acute bioavailability feeding study in two groups Ileostomists n 10 and health adults N10 as described below Prior to attending the visit participants were asked to follow a restriction diet for 48 hours before the study and also during the 24 hours of the study clinic visit which involved the intake of food containing low levels of polyphenols
Ileostomists n10 Twenty four hours before clinic visit the participant started a urine collection and were asked to fast from 9pm the night before the visit ie no food taken overnight and no breakfast On the morning of the study day the participants were asked to attend the clinic bringing their overnight stoma bag The 24 hr urine sample was provided and the overnight stoma bag was removed and replaced with a new stoma bag by the participant and passed to the researcher A cannula was fitted in the participants arm by a qualified phlebotomist and a blood sample 14 ml 6 ml draw off 8ml sample collected The participant was given 300 g of mango purée to consume Blood samples 14 ml 6 ml draw off 8ml sample were collected at hourly intervals for 8 hrs from the cannula 0 0511523468 and 24 hrs Urine was collected between 0-4 hrs 4-8hrs and 8-24 hrs a fresh sample bottle was provided at each time point Ileal samples were collected at 0-4 hrs 4-8hrs and 8-24 hrs the stoma bag was removed and replaced with a new stoma bag by the participant at each sampling point A restriction diet lunch was provided to the participant after the 4 hr blood draw After the 8 hr sample the participant was free to return home The next morning the participant returned to the clinic and the 24 hr samples blood urine ileal collected The urine ileal samples were collected and normal a normal phlebotomy draw will be used to collect the 24 hr blood sample The participant is then finished the study was free to return to their normal diet
Ileostomist participants each provided 4 ileal fluid samples 4 urine samples and 10 blood samples over the sampling period
Healthy participants n10 Twenty four hours before clinic visit the participant started a urine collection they were asked to fast from 9pm the night before the visit ie no food taken overnight and no breakfast On the morning of the study day the participant was asked to attend the clinic The 24 hr urine sample was collected and a faecal sample was provided A cannula was fitted in the participants arm by a qualified phlebotomist and a blood sample 14 ml 6 ml draw off 8ml sample collected The participant was then given 300 g of mango purée to consume Blood samples 14 ml 6 ml draw off 8ml sample were collected at hourly intervals for 8 hrs from the cannula 0 0511523468 and 24 hrs Urine samples were collected between 0-4 hrs 4-8hrs and 8-24 hrs a fresh sample bottle was provided at each time point A restriction diet lunch was provided to the participant after the 4 hr blood draw After the 8 hr sample the participant was free to return home The next morning the participant returned to the clinic and the 24 hr samples blood urine faecal collected The urine and faecal samples were collected and normal a normal phlebotomy draw was used to collect the 24 hr blood sample The participant then finished the study and was free to return to their normal diet
Healthy adult participants each provided in total 2 faecal samples 4 urine samples and 10 blood samples over the sampling period
Detailed Description:
None
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