Bioavailability and Bioactivity of Mango Polyphenols.

Not Applicable

Completed

• Conditions: Nutrition, Healthy
• Interventions: Dietary Supplement: Mango puree

• Registration Number: NCT06182540
• Lead Sponsor: University of Ulster

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 delivery/absorption of phytochemicals from a complex food matrix such as mango puree. Consequently, a paucity of data exists on the bioavailability and metabolism of (poly)phenolic compounds following ingestion of fresh mango puree either using targeted or untargeted metabolomics approaches. Mango puree (poly)phenolic bioavailability in humans (both healthy and ilesotomists) will be investigated using both targeted and untargeted metabolomics; further we will establish the bioactivity of mango (poly)phenols with respect to gastrointestinal health. A comprehensive understanding of the bioavailability of fresh mango puree (polyp)henols, 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 (N=10), 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 (n=10) Twenty four hours before clinic visit, the participant started a urine collection, and were asked to fast from 9pm the night before the visit (i.e. 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, 0.5,1,1.5,2,3,4,6,8 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 (n=10) Twenty four hours before clinic visit, the participant started a urine collection, they were asked to fast from 9pm the night before the visit (i.e. 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, 0.5,1,1.5,2,3,4,6,8 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

Not available

Study Timeline

• Study Start: 2020-01-02
• Primary Completion: 2020-02-27
• Study Completion: 2020-02-27
• Status Verified: 2023-11
• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-12-12
• Last Update Submitted: 2023-12-12
• Study First Posted: 2023-12-27
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ileostomy cohort	Mango puree	-
Non-Ileostomy cohort	Mango puree	-

Primary Outcome Measures

Name	Time	Method
Quantification of urinary (poly)phenols and microbially derived metabolities in participants with colon compared to without colon (ileostomates).	Change over 24 hours	Quantification of polyphenols via LC-MS/MS
Quantification of faecal (poly)phenols and microbially derived metabolities in participants with colon compared to without colon (ileostomates).	Change over 24 hours	Quantification of polyphenols via LC-MS/MS
Quantification of circulating (blood) (poly)phenols and microbially derived metabolities in participants with colon compared to without colon (ileostomates).	Change over 24 hours compared	Quantification of polyphenols via LC-MS/MS

Secondary Outcome Measures

Name	Time	Method
Ileal fluid polyphenolic metabolites	Change over 24 hours	Mass spectrometry analysis of In vitro gut model colonic fermentation of ileal fluid (µmol/L)
Ileal fluid microbial mediated metabolites	Change over 24 hours	Mass spectrometry analysis of In vitro gut model colonic fermentation of ileal fluid (µmol/L)

Trial Locations

Locations (1)

Human Intervention Studies Unit, Ulster Univeristy; 🇬🇧 Coleraine, N.Ireland, United Kingdom