Physiological Effect of Ataulfo Mango (Manguifera Indica) Beverage in Exercise

June 7, 2017 updated by: Universidad Autonoma de Ciudad Juarez

Physiological Response to Ataulfo Mango Pulp and Peel Beverages in Exercise

The aim of this study is to assess the antioxidant capacity of two mango base beverages (AM1, AM2), against exercise-induced oxidative stress.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction. The post-consumption physiological effect of mango cv. "Ataulfo" pulp (MP) and peel (MC) in humans before exercise has been poorly evaluated.

Objective. To evaluate the physiological response, to consumption of two mango base beverages, AM1 (200g MP/ 600mL water) and AM2 (160g MP; 40g MC / 600mL water), before and after a submaximal exercise test.

Methods. The antioxidant profile and physicochemical characteristics of AM1 and AM2 were evaluated. Several cardiorespiratory, anthropometric and body composition parameters of 19 university students, prior to the consumption of AM1, AM2 and water, were evaluated in three non-consecutive sessions (self-control cases). The glycemic, lactic and antioxidant (FRAP), uric acid (AU), reduced glutathione (GSH) and lipid oxidation (TBARS) and protein carbonyls (PC) responses were evaluated in plasma before and after an incremental cycle ergometer exercise test.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • healthy male
  • university student
  • no alcohol, cigar or drugs consumption

Exclusion Criteria:

  • no antioxidant supplement or ergogenic consumption
  • health issues with performing physical activity

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AM1
Mango pulp beverage
Dietary supplement: Mango pulp beverage

The subject consumes mango pulp beverage (200 g mango pulp + 600 mL water). 2 hours later subject performs the exercise test.

Washout: 1 week washout period prior to the administration of this intervention to avoid possible carryover effect.

Other Names:
  • AM1
  • 200 g mango pulp + 600 mL water
Experimental: AM2
Mango pulp and peel beverage
Dietary supplement: Mango pulp and peel beverage

The subject consumes mango pulp and peel beverage (160 g mango pulp + 40 g mango peel + 600 mL water). 2 hours later subject performs the exercise test.

Washout: 1 week washout period prior to the administration of this intervention to avoid possible carryover effect.

Other Names:
  • AM2
  • 160 g mango pulp + 40 g mango peel + 600 mL water
Placebo Comparator: Control
Control beverage
Dietary supplement: Control beverage

The subject consumes control beverage (600 mL water). 2 hours later subject performs the exercise test.

Washout: 1 week washout period prior to the administration of this intervention to avoid possible carryover effect.

Other Names:
  • 600 mL water

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Antioxidant capacity change
Time Frame: 0 min (before beverage intake), 9-15 min (immediately after exercise test)
Assessed by FRAP change. Blood samples were drawn from the antecubital vein into EDTA test tubes at rest, before beverage intake, and immediately following the exercise test. Samples were then centrifuged at 5000 rpm for 10 min at 4°C to obtain plasma, which was withdrawn and separated into eppendorf vials, maintained at -80°C until further biochemical analysis.
0 min (before beverage intake), 9-15 min (immediately after exercise test)
Antioxidant capacity change
Time Frame: 0 min (before beverage intake), 9-15 (immediately after exercise test)
Assessed by uric acid concentration change. Blood samples were drawn from the antecubital vein into EDTA test tubes at rest, before beverage intake, and immediately following the exercise test. Samples were then centrifuged at 5000 rpm for 10 min at 4°C to obtain plasma, which was withdrawn and separated into eppendorf vials, maintained at -80°C until further biochemical analysis.
0 min (before beverage intake), 9-15 (immediately after exercise test)
Antioxidant capacity change
Time Frame: 0 min (before beverage intake), 9-15 (immediately after exercise test)
Assessed by reduced glutathione concentration change. Blood samples were drawn from the antecubital vein into EDTA test tubes at rest, before beverage intake, and immediately following the exercise test. Samples were then centrifuged at 5000 rpm for 10 min at 4°C to obtain plasma, which was withdrawn and separated into eppendorf vials, maintained at -80°C until further biochemical analysis.
0 min (before beverage intake), 9-15 (immediately after exercise test)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oxidative stress change
Time Frame: 0 min (before beverage intake), 9-15 (immediately after exercise test)
Assessed by TBARS concentration change. Blood samples were drawn from the antecubital vein into EDTA test tubes at rest, before beverage intake, and immediately following the exercise test. Samples were then centrifuged at 5000 rpm for 10 min at 4°C to obtain plasma, which was withdrawn and separated into eppendorf vials, maintained at -80°C until further biochemical analysis.
0 min (before beverage intake), 9-15 (immediately after exercise test)
Oxidative stress change
Time Frame: 0 min (before beverage intake), 9-15 (immediately after exercise test)
Assessed by protein carbonyls concentration change. Blood samples were drawn from the antecubital vein into EDTA test tubes at rest, before beverage intake, and immediately following the exercise test. Samples were then centrifuged at 5000 rpm for 10 min at 4°C to obtain plasma, which was withdrawn and separated into eppendorf vials, maintained at -80°C until further biochemical analysis.
0 min (before beverage intake), 9-15 (immediately after exercise test)
Lactic acid concentration change
Time Frame: 0 min (before performing exercise test), 3 min, 6 min, 9 min, 12 min, 15 min (during exercise test)
Assessed by lactic acid concentration change. Capillary blood samples were taken from the fingertip, using a lancet and analyzed (YSI modelo 1500, Yellow Springs, USA)
0 min (before performing exercise test), 3 min, 6 min, 9 min, 12 min, 15 min (during exercise test)
Postprandial glycemic change
Time Frame: 0 min (before beverage intake), 30 min, 60 min, 90 min, 120 min (after beverage intake)
Assessed by blood glucose concentration change. Capillary blood samples were taken from the fingertip, using a lancet, and analyzed (ReliOn Confirm/micro Test Strips ARKRAY, USA)
0 min (before beverage intake), 30 min, 60 min, 90 min, 120 min (after beverage intake)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Autonoma de Ciudad Juarez

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Abraham Wall-Medrano, PhD, Universidad Autonoma de Ciudad Juarez
  • Principal Investigator: Gregorio Chavez-Treviño, MS, Universidad Autonoma de Ciudad Juarez

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UACJ-ICB-2017-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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