Nutrition, HealthyMANGUTNCT06182540
Bioavailability and Bioactivity of Mango Polyphenols.
A study testing Mango puree in people with Nutrition, Healthy, run by University of Ulster at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Healthy
- What is being tested?
- Mango puree
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Jan 2020to 27 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Adults <18 or >70 years at recruitment
- Current smokers
- Pregnant/lactating females
- Absence of gastro intestinal disease (e.g. coeliac disease; cancer)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster Univeristy
Coleraine, N.Ireland, BT52 1SA
About this study
Official title: Bioavailability and Bioactivity of Mango (Poly)Phenols on Gut Health.
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.
Read more
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
- Being tested
- Mango puree
- Keywords
- Mango, Polyphenols, Ileostomy, GI tract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mango pureeDietary supplement
Mango puree 300g
| Study group | Role | What they receive |
|---|---|---|
| Ileostomy cohort | Experimental | Not described Receives: Dietary Supplement: Mango puree |
| Non-Ileostomy cohort | Experimental | Not described Receives: Dietary Supplement: Mango puree |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of circulating (blood) (poly)phenols and microbially derived metabolities in participants with colon compared to without colon (ileostomates).
Quantification of polyphenols via LC-MS/MS
Measured: Change over 24 hours compared
Quantification of urinary (poly)phenols and microbially derived metabolities in participants with colon compared to without colon (ileostomates).
Quantification of polyphenols via LC-MS/MS
Measured: Change over 24 hours
Quantification of faecal (poly)phenols and microbially derived metabolities in participants with colon compared to without colon (ileostomates).
Quantification of polyphenols via LC-MS/MS
Measured: Change over 24 hours
Secondary outcomes (2)
Ileal fluid polyphenolic metabolites
Mass spectrometry analysis of In vitro gut model colonic fermentation of ileal fluid (µmol/L)
Measured: Change over 24 hours
Ileal fluid microbial mediated metabolites
Mass spectrometry analysis of In vitro gut model colonic fermentation of ileal fluid (µmol/L)
Measured: Change over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start2 Jan 2020
- Primary completion27 Feb 2020
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nutrition, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- Acute intervention in populations with and without colon
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Andalusian Institute of Agricultural and Fisheries Research and Training
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182540
- Sponsor's protocol ID
- REC/19/0097
- Acronym
- MANGUT
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caceres-Jimenez S, Dobani S, Pourshahidi LK, Gill CIR, Ordonez-Diaz JL, Moreno-Rojas JM, Crozier A, Pereira-Caro G. Bioaccessibility and colonic catabolism of carotenoids from mango puree (cv. Osteen): comparison of ileal fluid content and products of in vitro digestion. Food Funct. 2026 May 26;17(10):4492-4505. doi: 10.1039/d6fo00765a.
PubMed 42065471Caceres-Jimenez S, Molinero N, Cueva C, Dobani S, Pourshahidi KL, Gill CIR, Tuohy KM, Moreno-Rojas JM, Crozier A, Bartolome B, Moreno-Arribas MV, Pereira-Caro G. Fecal fermentation of human ileal fluid after mango intake impacts on colonic microbiota and microbial (poly)phenol catabolism. Food Res Int. 2025 Dec;221(Pt 1):117217. doi: 10.1016/j.foodres.2025.117217. Epub 2025 Aug 11.
PubMed 41606941Caceres-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.
PubMed 40928077Caceres-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.
PubMed 39426756
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Bioactivity of Mango (Poly)Phenols on Gut Health.
- ClinicalTrials.gov ID
- NCT06182540
- Acronym / sponsor ID
- MANGUT / REC/19/0097
- Conditions
- Nutrition, Healthy
- Keywords
- Mango, Polyphenols, Ileostomy, GI tract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Andalusian Institute of Agricultural and Fisheries Research and Training
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Acute intervention in populations with and without colon
| Arm | Type | Receives |
|---|---|---|
| Ileostomy cohort | Experimental | Dietary Supplement: Mango puree |
| Non-Ileostomy cohort | Experimental | Dietary Supplement: Mango puree |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Non-free-living adults
- Adults <18 or >70 years at recruitment
- Current smokers
- Pregnant/lactating females
- Ileostomy <1.5-year post-operative
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mango pureeMango puree 300g | Dietary supplement | Ileostomy cohort, Non-Ileostomy cohort |
Primary outcome
Quantification of circulating (blood) (poly)phenols and microbially derived metabolities in participants with colon compared to without colon (ileostomates).
Time frame: Change over 24 hours compared
Quantification of polyphenols via LC-MS/MS
Quantification of urinary (poly)phenols and microbially derived metabolities in participants with colon compared to without colon (ileostomates).
Time frame: 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).
Time frame: Change over 24 hours
Quantification of polyphenols via LC-MS/MS
2 secondary outcomes
Ileal fluid polyphenolic metabolites
Time frame: Change over 24 hours
Ileal fluid microbial mediated metabolites
Time frame: Change over 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Derived from this study: PubMed 42065471Caceres-Jimenez S, Dobani S, Pourshahidi LK, Gill CIR, Ordonez-Diaz JL, Moreno-Rojas JM, Crozier A, Pereira-Caro G. Bioaccessibility and colonic catabolism of carotenoids from mango puree (cv. Osteen): comparison of ileal fluid content and products of in vitro digestion. Food Funct. 2026 May 26;17(10):4492-4505. doi: 10.1039/d6fo00765a.
- Derived from this study: PubMed 41606941Caceres-Jimenez S, Molinero N, Cueva C, Dobani S, Pourshahidi KL, Gill CIR, Tuohy KM, Moreno-Rojas JM, Crozier A, Bartolome B, Moreno-Arribas MV, Pereira-Caro G. Fecal fermentation of human ileal fluid after mango intake impacts on colonic microbiota and microbial (poly)phenol catabolism. Food Res Int. 2025 Dec;221(Pt 1):117217. doi: 10.1016/j.foodres.2025.117217. Epub 2025 Aug 11.
- Derived from this study: PubMed 40928077Caceres-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.
- Derived from this study: PubMed 39426756Caceres-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mango puree in people with Nutrition, Healthy, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of circulating (blood) (poly)phenols and microbially derived metabolities in participants with colon compared to without colon (ileostomates). (time frame: Change over 24 hours compared). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06182540, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.