Clinical trial NCT02227615: Absorption of Mango in Healthy Individuals
Official title: Profile of Metabolites After the Intake of Mango (Mangifera Indica, l.) Var. Keitt in Humans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Absorption; Chemicals
Lead sponsor: Texas A&M University
Sponsor class: OTHER
First posted: 2014-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: Inclusion Criteria:

* No medical history of digestive disorders or chronic diseases

Exclusion Criteria:

* Have medical history of digestive disorders or chronic diseases

Primary outcomes:
measure: Change from baseline in the levels of metabolites of gallic acid in urine after mango intake.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: College station
country: United States
facility: Exercise & Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas A&M University
state: Texas
Study officials:
affiliation: Texas A&M University
name: Susanne Talcott, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: