CClinicalTrials.gg
Status unknownNCT02227615Updated Oct 18, 2016

Absorption of Mango in Healthy Individuals

An interventional study of Mango polyphenolics and Sugary beverage in Absorption; Chemicals, sponsored by Texas A&M University. Status unknown at 1 site in United States. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-18.

Sponsored by Texas A&M University · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study summary

The objective of this research is to characterize the urinary metabolites produced after the consumption of mango pulp in an effort to begin to characterize the bioavailability of the major group of polyphenolics in mango, ester-linked gallic acids, and to provide new insight into their in vivo physiological behavior.

Read the detailed description

Eleven healthy volunteers (2 male, 9 female) who had no medical history of digestive disorders or chronic diseases participated in the 10-day mango consumption study. They were aged between 21-38 years and with a weight between 45-95 kg. Participants were asked to stop taking dietary supplements for 1 week prior to the study begin and study duration and asked to avoid excessive exercise and alcohol consumption 3 days prior to the start of the study day 1 and study day 10. Participants were also required to fill out a 72-hour nutritional report at home that detailed their food consumption over the previous 3 days leading up to the first and tenth day and were reviewed for compliance. All participants fasted from fruit and vegetables, coffee and tea one day prior to study day 1 and 10 and were asked to bring in a stool sample collected prior to consumption of mango on the first day of the study. After an overnight fast of at least 12 hours, urine collections were made (baseline) and a baseline blood draw was taken from each participant. Each participant was given 400 grams of mango to consume and urine collections were made at 0-3, 3-6, 6-8, and 8-12 hours. The volume of urine was recorded and an aliquot immediately frozen at -80°C until analysis. Blood samples were also taken at 0.5, 1, 2, 3, 4, 6, 8, and 12hrs, collected in heparinized tubes and centrifuged for 10 mins at 4000 x g, 4°C. Supernatant (plasma) was aliquoted into 2mL samples, acidified with 50 μL 85% formic acid, and immediately frozen at -80° C until analysis. Participants were given 400 grams of mango to consume daily for the next eight days and the study design was repeated again on the 10th day. After completion of the tenth day of study, stool samples were collected and immediately frozen at -20°C for microbial analysis.

02

Conditions studied

  • Absorption; Chemicals
03

In context

Lead sponsor

Texas A&M University is the lead sponsor of 123 studies on the registry; 23 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 2 (29%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No medical history of digestive disorders or chronic diseases

Exclusion criteria

Exclusion Criteria:

  • Have medical history of digestive disorders or chronic diseases
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Placebo comparator
    Sugary beverage

    Sugary beverage

    Dietary Supplement: Sugary beverage

  • Experimental
    Mango beverage

    Mango polyphenolics

    Dietary Supplement: Mango polyphenolics

Interventions

  • Dietary supplementMango polyphenolics

    Frozen Mango (Keitt) packs provided to subjects.

  • Dietary supplementSugary beverage

    15.7g sugar, 3.8g pectin and 0.05g citric acid was added in 100ml of the control beverage.

06

What researchers measure

Primary outcomes

  1. Change from baseline in the levels of metabolites of gallic acid in urine after mango intake.

    Aliquoted urine samples were thawed and centrifuged at 13,000 x g for 10 mins at 4°C immediately prior to analysis by HPLC-MSn. All quantification of metabolites (pyrogalloyl-O-glucuronide, O-methyl-gallic acid, O-methylgallic acid-O-sulfate, O-methylpyrogalloyl-O-sulfate, pyrogalloyl-O-sulfate, deoxypyrogallol-O-sulfate, O-methylpyrogalloyl-O-sulfate) was performed in full MS and expressed as gallic acid equivalents. To standardize the concentration of metabolites for the sake of comparison across varying weights, heights, and volume of urine collected by each participant; urinary creatinine concentrations were calculated for each sample using a routine Creatinine enzyme assay kit (Sigma-Aldrich). All values are expressed as mg of standard/10 mg creatinine (mg gallic acid equivalent /10mg creatinine).

    Time frame: 1 year

07

Study locations

1 site
  • Exercise & Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas A&M University
    College station, Texas 77845, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02227615
Lead sponsor
Texas A&M University
Responsible party
Sponsor
First posted
Aug 28, 2014
Start date
Mar 2013
Primary completion
Dec 2016 (estimated)
Completion
Dec 2017 (estimated)
Last update
Oct 18, 2016

Study contacts

Susanne Talcott, Ph.D.
principal investigator · Texas A&M University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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