Bioavailability and Bioactivity of Mango Polyphenols.

NCT ID: NCT06182540

Last Updated: 2023-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2020-02-27

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.

Conditions

Nutrition, Healthy

Keywords

Mango; Polyphenols; Ileostomy; GI tract

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ileostomy cohort

Group Type: EXPERIMENTAL

Mango puree

Intervention Type: DIETARY_SUPPLEMENT

Mango puree 300g

Non-Ileostomy cohort

Group Type: EXPERIMENTAL

Mango puree

Intervention Type: DIETARY_SUPPLEMENT

Mango puree 300g

Interventions

Mango puree

Mango puree 300g

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Free-living, adult with an ileostomy, ≥1.5-years post-operative
• Aged 18-70 years at recruitment
• Non-smokers

• Free-living, apparently healthy adults
• Aged 18-70 years at recruitment
• Non-smokers
• No ileostomy

Exclusion Criteria

• Non-free-living adults
• Adults <18 or >70 years at recruitment
• Current smokers
• Pregnant/lactating females
• Ileostomy <1.5-year post-operative

• Non-free-living adults
• Adults <18 or >70 years at recruitment
• Current smokers
• Pregnant/lactating females
• Absence of gastro intestinal disease (e.g. coeliac disease; cancer)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Andalusian Institute of Agricultural and Fisheries Research and Training

UNKNOWN

Sponsor Role: collaborator

University of Ulster

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Human Intervention Studies Unit, Ulster Univeristy

Coleraine, N.Ireland, United Kingdom

Countries

United Kingdom

References

Caceres-Jimenez S, Pereira-Caro G, Dobani S, Pourshahidi K, Gill CIR, Moreno-Rojas JM, Almutairi TM, Clifford MN, Crozier A. Interpretation of plasma pharmacokinetics and urinary excretion of phenolic metabolites and catabolites derived from (poly)phenols following ingestion of mango by ileostomists and subjects with a full gastrointestinal tract: complications associated with endogenous and ingested phenylalanine and tyrosine. Food Funct. 2025 Sep 29;16(19):7761-7778. doi: 10.1039/d5fo02745d.

Reference Type: DERIVED

PMID: 40928077 (View on PubMed)

Caceres-Jimenez S, Pereira-Caro G, Dobani S, Pourshahidi K, Gill CIR, Moreno-Rojas JM, Ordonez-Diaz JL, Almutairi TM, Clifford MN, Crozier A. Bioavailability of mango (poly)phenols: An evaluation of the impact of the colon, and phenylalanine and tyrosine on the production of phenolic catabolites. Free Radic Biol Med. 2024 Nov 20;225:605-616. doi: 10.1016/j.freeradbiomed.2024.10.289. Epub 2024 Oct 18.

Reference Type: DERIVED

PMID: 39426756 (View on PubMed)

Other Identifiers

REC/19/0097

Identifier Type: -

Identifier Source: org_study_id