NCT02227615

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 28, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 18, 2016

Status Verified

October 1, 2016

Enrollment Period

3.8 years

First QC Date

June 4, 2014

Last Update Submit

October 14, 2016

Conditions

Outcome Measures

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).

    1 year

Study Arms (2)

Sugary beverage

PLACEBO COMPARATOR

Sugary beverage

Dietary Supplement: Sugary beverage

Mango beverage

EXPERIMENTAL

Mango polyphenolics

Dietary Supplement: Mango polyphenolics

Interventions

Mango polyphenolicsDIETARY_SUPPLEMENT

Frozen Mango (Keitt) packs provided to subjects.

Mango beverage
Sugary beverageDIETARY_SUPPLEMENT

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

Sugary beverage

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No medical history of digestive disorders or chronic diseases

You may not qualify if:

  • Have medical history of digestive disorders or chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise & Sport Nutrition Laboratory (ESNL) in the Department of Health and Kinesiology at Texas A&M University

College Station, Texas, 77845, United States

Location

Study Officials

  • Susanne Talcott, Ph.D.

    Texas A&M University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2014

First Posted

August 28, 2014

Study Start

March 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2017

Last Updated

October 18, 2016

Record last verified: 2016-10

Locations