- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02227615
Absorption of Mango in Healthy Individuals
October 14, 2016 updated by: Texas A&M University
Profile of Metabolites After the Intake of Mango (Mangifera Indica, l.) Var. Keitt in Humans
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Texas
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College station, Texas, United States, 77845
- Exercise & Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas A&M University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- No medical history of digestive disorders or chronic diseases
Exclusion Criteria:
- Have medical history of digestive disorders or chronic diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 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
|
Frozen Mango (Keitt) packs provided to subjects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in the levels of metabolites of gallic acid in urine after mango intake.
Time Frame: 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).
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Susanne Talcott, Ph.D., Texas A&M University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Anticipated)
December 1, 2016
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
June 4, 2014
First Submitted That Met QC Criteria
August 26, 2014
First Posted (Estimate)
August 28, 2014
Study Record Updates
Last Update Posted (Estimate)
October 18, 2016
Last Update Submitted That Met QC Criteria
October 14, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- TexasAMU-IRB2011-0735F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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