Absorption of Mango in Healthy Individuals

Sponsor
Texas A&M University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02227615
Collaborator
(none)
30
1
2
57
0.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Mango polyphenolics
  • Dietary Supplement: Sugary beverage
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Profile of Metabolites After the Intake of Mango (Mangifera Indica, l.) Var. Keitt in Humans
Study Start Date :
Mar 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Sugary beverage

Sugary beverage

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

Experimental: Mango beverage

Mango polyphenolics

Dietary Supplement: Mango polyphenolics
Frozen Mango (Keitt) packs provided to subjects.

Outcome Measures

Primary Outcome Measures

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

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • No medical history of digestive disorders or chronic diseases
Exclusion Criteria:
  • Have medical history of digestive disorders or chronic diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 Exercise & Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas A&M University College station Texas United States 77845

Sponsors and Collaborators

  • Texas A&M University

Investigators

  • Principal Investigator: Susanne Talcott, Ph.D., Texas A&M University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Texas A&M University
ClinicalTrials.gov Identifier:
NCT02227615
Other Study ID Numbers:
  • TexasAMU-IRB2011-0735F
First Posted:
Aug 28, 2014
Last Update Posted:
Oct 18, 2016
Last Verified:
Oct 1, 2016

Study Results

No Results Posted as of Oct 18, 2016