Exercise in Hypoxia and Nitrate Supplementation in Athletes: is the Whole Greater Than the Sum of Its Parts?

December 4, 2024 updated by: Ana Sousa, University of Trás-os-Montes and Alto Douro
Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions.

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

Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions. It is hypothesized that the combined effect of these interventions will promote an additional performance and health improvement in this population at sea-level and altitude conditions, compared with the single effect.

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.
30

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

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

  • Portugal
      • Vila Real, Portugal
        • University of Trás-os-Montes e Alto-Douro

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • trained male subjects, regularly involved in competitive running, cycling and/ or triathlon events (4-5 times per week) in the past five years

Exclusion Criteria:

  • smoking or other chronic issues
  • using medication or dietary supplements in the last 3 months, or during the duration of the study
  • being exposed to altitude (≥2000 m) in the last 3 months

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: HNO: High intensity interval training (HIIT) + nitrate supllementation (NO3-).
Performed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normobaric hypoxia conditions (FiO2=~13%, ~3000 m) with NO3- supplement.
Combination product: Nitrate + Hypoxia
The combined effect of nitrate supplementation and hypoxia training on both performance and health at sea-level and altitude conditions.
Other Names:
  • Beetroot Juice + Atitude training
Active Comparator: HPL: High intensity interval training (HIIT) + placebo supllementation.
Performed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normobaric hypoxia conditions (FiO2=~13%, ~3000 m) with placebo supplement.
Dietary supplement: Placebo + Hypoxia
The combined effect of placebo supplementation and hypoxia training on both performance and health at sea-level and altitude conditions.
Other Names:
  • Placebo Juice + Atitude training
Placebo Comparator: CON: High intensity interval training (HIIT) + placebo supllementation.
Performed 12 high-intensity interval-training (HIIT) sessions during a 4-week period (3 sessions/ week) under normoxic conditions (FiO2=~20.9%) with placebo supplement.
Other: Control
The combined effect of placebo supplementation and normoxia training on both performance and health at sea-level and altitude conditions.
Other Names:
  • Placebo Juice + Normoxia training

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
Performance adaptations
Time Frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Time-to-task failure (time sustained)
Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Performance adaptations
Time Frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Time trials (time performed)
Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Performance adaptations
Time Frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
VO2 kinetics (time constant and amplitude of fast and slow oxygen components)
Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Cardiovascular and neuromuscular adaptations
Time Frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Maximal oxygen uptake (VO2max: absolute and relative value)
Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Cardiovascular and neuromuscular adaptations
Time Frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Lactate threshold (absolute and percentage of VO2max)
Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Cardiovascular and neuromuscular adaptations
Time Frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Muscular oxygen saturation (SmO2)
Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Skeletal muscle adaptations
Time Frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Oxidative enzyme activity (cytochrome oxidase subunit IV), citrate synthase, transcription factors (HIF-1alpha and PGC-1alpha) and GLUT4 - assessed through standard enzymatic fluorometric assay and western bllotting
Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Skeletal muscle adaptations
Time Frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Mitochondrial and capillary density, capillary-to-fibre ratio and fibre cross-section area - cryosections cut with a cryostat and further samples analysed by fluorescence microscopy
Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Haematological adaptations
Time Frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Blood pressure (Hmmg), mean arterial pressure (calculated as 1/3 * systolic pressure + 2/3 * diastolic pressure)
Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Haematological adaptations
Time Frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Plasma [NO2-] and [NO3-], erythropoietin (EPO), haemoglobin (Hb) and haematocrit (Hct) - all assays on plasma sample analysed by spectrophometry
Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Oxidative stress and antioxidant markers adaptations
Time Frame: Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)
Nitrotyrosine, malondialdehyde, ferric-reducing antioxidant power and superoxide dismutase concentrations - all assays on plasma sample analysed by spectrophometry
Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)

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
Sleep and cardiac autonomic activity adaptations
Time Frame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep duration (minutes)
Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Time Frame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep efficiency (%)
Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Time Frame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Wake up time (hours: minutes)
Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Time Frame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Resting heart rate (bpm)
Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Sleep and cardiac autonomic activity adaptations
Time Frame: Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)
Heart rate variability (lnRMSSD)
Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)

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.
University of Trás-os-Montes and Alto Douro

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.
  • Principal Investigator: Ana Sousa, PhD, University of Maia

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.
February 1, 2019

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.
July 22, 2020

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.
July 22, 2020

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).
July 24, 2024

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.
December 4, 2024

First Posted (Estimated)

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.
December 11, 2024

Study Record Updates

Last Update Posted (Estimated)

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.
December 11, 2024

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.
December 4, 2024

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.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • Hypoxia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study overview, participation criteria, study plan, contacts

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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