Exercise-induced Oxidative StressNCT03182543
Physiological Effect of Ataulfo Mango (Manguifera Indica) Beverage in Exercise
A study testing Mango pulp beverage and Mango pulp and peel beverage in people with Exercise-induced Oxidative Stress, run by Universidad Autonoma de Ciudad Juarez.
Trial summary
The aim of this study is to assess the antioxidant capacity of two mango base beverages (AM1, AM2), against exercise-induced oxidative stress. Read more about this study
- Who is it for?
- Ages 17 to 28 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise-induced Oxidative Stress
- What is being tested?
- Mango pulp beverage and Mango pulp and peel beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 28 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- healthy male
- university student
- no alcohol, cigar or drugs consumption
Who cannot join
- no antioxidant supplement or ergogenic consumption
- health issues with performing physical activity
About this study
Official title: 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.
Read the 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.
- Conditions
- Exercise-induced Oxidative Stress
- Being tested
- Mango pulp beverage, Mango pulp and peel beverage, Control beverage
- Keywords
- Exercise, Oxidative stress, Antioxidant
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mango pulp beverageDietary supplement
Also called AM1, 200 g mango pulp + 600 mL water
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.
Mango pulp and peel beverageDietary supplement
Also called AM2, 160 g mango pulp + 40 g mango peel + 600 mL water
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.
Control beverageDietary supplement
Also called 600 mL water
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.
| Study group | Role | What they receive |
|---|---|---|
| AM1 | Experimental | Mango pulp beverage Receives: Dietary Supplement: Mango pulp beverage |
| AM2 | Experimental | Mango pulp and peel beverage Receives: Dietary Supplement: Mango pulp and peel beverage |
| Control | Placebo comparator | Control beverage Receives: Dietary Supplement: Control beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antioxidant capacity change
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.
Measured: 0 min (before beverage intake), 9-15 min (immediately after exercise test)
Antioxidant capacity change
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.
Measured: 0 min (before beverage intake), 9-15 (immediately after exercise test)
Antioxidant capacity change
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.
Measured: 0 min (before beverage intake), 9-15 (immediately after exercise test)
Secondary outcomes (4)
Oxidative stress change
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.
Measured: 0 min (before beverage intake), 9-15 (immediately after exercise test)
Oxidative stress change
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.
Measured: 0 min (before beverage intake), 9-15 (immediately after exercise test)
Lactic acid concentration change
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)
Measured: 0 min (before performing exercise test), 3 min, 6 min, 9 min, 12 min, 15 min (during exercise test)
Postprandial glycemic change
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)
Measured: 0 min (before beverage intake), 30 min, 60 min, 90 min, 120 min (after beverage intake)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start1 Jan 2017
- Primary completion28 Feb 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Exercise-induced Oxidative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The prescription of the treatments (AM1, AM2) and control (water) was randomized. The subject consumed 600mL of AM1, AM2 or water. 2 hours later subject performed the exercise test. Next treatment was evaluated after a week of wash-out.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Ciudad Juarez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abraham Wall-Medrano, PhD, Study director, Universidad Autónoma de Ciudad JuárezGregorio Chavez-Treviño, MS, Principal investigator, Universidad Autónoma de Ciudad Juárez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182543
- Sponsor's protocol ID
- UACJ-ICB-2017-01
- Status last verified
- Jun 2017
- First submitted
- 29 May 2017
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez-Parrilla E, De La Rosa LA, Legarreta P, Saenz L, Rodrigo-Garcia J, Gonzalez-Aguilar GA. Daily consumption of apple, pear and orange juice differently affects plasma lipids and antioxidant capacity of smoking and non-smoking adults. Int J Food Sci Nutr. 2010 Jun;61(4):369-80. doi: 10.3109/09637480903514041.
PubMed 20109132Ramos-Jimenez A, Hernandez-Torres RP, Wall-Medrano A, Torres-Duran PV, Juarez-Oropeza MA, Solis Ceballos JA. Acute physiological response to indoor cycling with and without hydration; case and self-control study. Nutr Hosp. 2013 Sep-Oct;28(5):1487-93. doi: 10.3305/nh.2013.28.5.6698.
PubMed 24160205Spirlandeli AL, Deminice R, Jordao AA. Plasma malondialdehyde as biomarker of lipid peroxidation: effects of acute exercise. Int J Sports Med. 2014 Jan;35(1):14-8. doi: 10.1055/s-0033-1345132. Epub 2013 Jun 14.
PubMed 23771832Wang CY, Haskell WL, Farrell SW, Lamonte MJ, Blair SN, Curtin LR, Hughes JP, Burt VL. Cardiorespiratory fitness levels among US adults 20-49 years of age: findings from the 1999-2004 National Health and Nutrition Examination Survey. Am J Epidemiol. 2010 Feb 15;171(4):426-35. doi: 10.1093/aje/kwp412. Epub 2010 Jan 15.
PubMed 20080809Wall-Medrano A, Olivas-Aguirre FJ, Velderrain-Rodriguez GR, Gonzalez-Aguilar A, de la Rosa LA, Lopez-Diaz JA, Alvarez-Parrilla E. [Mango: agroindustrial aspects, nutritional/functional value and health effects]. Nutr Hosp. 2014 Nov 1;31(1):67-75. doi: 10.3305/nh.2015.31.1.7701. Spanish.
PubMed 25561099
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Response to Ataulfo Mango Pulp and Peel Beverages in Exercise
- ClinicalTrials.gov ID
- NCT03182543
- Acronym / sponsor ID
- UACJ-ICB-2017-01
- Conditions
- Exercise-induced Oxidative Stress
- Keywords
- Exercise, Oxidative stress, Antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Universidad Autonoma de Ciudad JuarezUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the antioxidant capacity of two mango base beverages (AM1, AM2), against exercise-induced oxidative stress.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The prescription of the treatments (AM1, AM2) and control (water) was randomized. The subject consumed 600mL of AM1, AM2 or water. 2 hours later subject performed the exercise test. Next treatment was evaluated after a week of wash-out.
| Arm | Type | Receives |
|---|---|---|
| AM1 | Experimental | Dietary Supplement: Mango pulp beverageMango pulp beverage |
| AM2 | Experimental | Dietary Supplement: Mango pulp and peel beverageMango pulp and peel beverage |
| Control | Placebo comparator | Dietary Supplement: Control beverageControl beverage |
Who may qualify
- Ages
- 17 to 28 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- healthy male
- university student
- no alcohol, cigar or drugs consumption
Key exclusion criteria (2 listed)
- no antioxidant supplement or ergogenic consumption
- health issues with performing physical activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mango pulp beverageAlso: AM1, 200 g mango pulp + 600 mL waterThe 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. | Dietary supplement | AM1 |
| Mango pulp and peel beverageAlso: AM2, 160 g mango pulp + 40 g mango peel + 600 mL waterThe 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. | Dietary supplement | AM2 |
| Control beverageAlso: 600 mL waterThe 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. | Dietary supplement | Control |
Primary outcome
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.
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.
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.
4 secondary outcomes
Oxidative stress change
Time frame: 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)
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)
Postprandial glycemic change
Time frame: 0 min (before beverage intake), 30 min, 60 min, 90 min, 120 min (after beverage intake)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
- Background: PubMed 20109132Alvarez-Parrilla E, De La Rosa LA, Legarreta P, Saenz L, Rodrigo-Garcia J, Gonzalez-Aguilar GA. Daily consumption of apple, pear and orange juice differently affects plasma lipids and antioxidant capacity of smoking and non-smoking adults. Int J Food Sci Nutr. 2010 Jun;61(4):369-80. doi: 10.3109/09637480903514041.
- Background: PubMed 24160205Ramos-Jimenez A, Hernandez-Torres RP, Wall-Medrano A, Torres-Duran PV, Juarez-Oropeza MA, Solis Ceballos JA. Acute physiological response to indoor cycling with and without hydration; case and self-control study. Nutr Hosp. 2013 Sep-Oct;28(5):1487-93. doi: 10.3305/nh.2013.28.5.6698.
- Background: PubMed 23771832Spirlandeli AL, Deminice R, Jordao AA. Plasma malondialdehyde as biomarker of lipid peroxidation: effects of acute exercise. Int J Sports Med. 2014 Jan;35(1):14-8. doi: 10.1055/s-0033-1345132. Epub 2013 Jun 14.
- Background: PubMed 20080809Wang CY, Haskell WL, Farrell SW, Lamonte MJ, Blair SN, Curtin LR, Hughes JP, Burt VL. Cardiorespiratory fitness levels among US adults 20-49 years of age: findings from the 1999-2004 National Health and Nutrition Examination Survey. Am J Epidemiol. 2010 Feb 15;171(4):426-35. doi: 10.1093/aje/kwp412. Epub 2010 Jan 15.
- Background: PubMed 25561099Wall-Medrano A, Olivas-Aguirre FJ, Velderrain-Rodriguez GR, Gonzalez-Aguilar A, de la Rosa LA, Lopez-Diaz JA, Alvarez-Parrilla E. [Mango: agroindustrial aspects, nutritional/functional value and health effects]. Nutr Hosp. 2014 Nov 1;31(1):67-75. doi: 10.3305/nh.2015.31.1.7701. Spanish.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abraham Wall-Medrano, PhD study director
Universidad Autónoma de Ciudad Juárez
Gregorio Chavez-Treviño, MS principal investigator
Universidad Autónoma de Ciudad Juárez
Questions about this trial
What is this clinical trial studying?
A study testing Mango pulp beverage and Mango pulp and peel beverage in people with Exercise-induced Oxidative Stress, run by Universidad Autonoma de Ciudad Juarez.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antioxidant capacity change (time frame: 0 min (before beverage intake), 9-15 min (immediately after exercise test)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182543, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.