This trial is active, not recruiting.

Condition absorption; chemicals
Treatments mango polyphenolics, sugary beverage
Sponsor Texas A&M University
Start date March 2013
End date December 2016
Trial size 30 participants
Trial identifier NCT02227615, TexasAMU-IRB2011-0735F


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose basic science
(Placebo Comparator)
Sugary beverage
sugary beverage
15.7g sugar, 3.8g pectin and 0.05g citric acid was added in 100ml of the control beverage.
Mango polyphenolics
mango polyphenolics
Frozen Mango (Keitt) packs provided to subjects.

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 20 years up to 40 years old.

Inclusion Criteria: - No medical history of digestive disorders or chronic diseases Exclusion Criteria: - Have medical history of digestive disorders or chronic diseases

Additional Information

Official title Profile of Metabolites After the Intake of Mango (Mangifera Indica, l.) Var. Keitt in Humans
Principal investigator Susanne Talcott, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Texas A&M University.