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

NCT06727656 | Completed DMC

• 1 other identifier: Hypoxia
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the combined effect of training in hypoxia and nitrate supplementation on the performance and health of athletes at sea-level and altitude conditions.

Conditions

Hypoxia

Outcome Measures

Primary Outcomes (11)

• Performance adaptations

  Time-to-task failure (time sustained)

  Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)

• Performance adaptations

  Time trials (time performed)

  Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)

• Performance adaptations

  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

  Maximal oxygen uptake (VO2max: absolute and relative value)

  Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)

• Cardiovascular and neuromuscular adaptations

  Lactate threshold (absolute and percentage of VO2max)

  Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)

• Cardiovascular and neuromuscular adaptations

  Muscular oxygen saturation (SmO2)

  Moment #1 (48hours pre-intervention) and moment #2 (48hours post-intervention)

• Skeletal muscle adaptations

  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

  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

  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

  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

  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 Outcomes (5)

• Sleep and cardiac autonomic activity adaptations

  Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)

• Sleep and cardiac autonomic activity adaptations

  Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)

• Sleep and cardiac autonomic activity adaptations

  Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)

• Sleep and cardiac autonomic activity adaptations

  Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)

• Sleep and cardiac autonomic activity adaptations

  Moment #1 (2 weeks pre-intervention - baseline) and moment #2 (4 weeks intervention)

Study Arms (3)

HNO: High intensity interval training (HIIT) + nitrate supllementation (NO3-).

EXPERIMENTAL

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

HPL: High intensity interval training (HIIT) + placebo supllementation.

ACTIVE COMPARATOR

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

CON: High intensity interval training (HIIT) + placebo supllementation.

PLACEBO COMPARATOR

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

Interventions

Nitrate + Hypoxia COMBINATION_PRODUCT

The combined effect of nitrate supplementation and hypoxia training on both performance and health at sea-level and altitude conditions.

Also known as: Beetroot Juice + Atitude training

HNO: High intensity interval training (HIIT) + nitrate supllementation (NO3-).

Placebo + Hypoxia DIETARY_SUPPLEMENT

The combined effect of placebo supplementation and hypoxia training on both performance and health at sea-level and altitude conditions.

Also known as: Placebo Juice + Atitude training

HPL: High intensity interval training (HIIT) + placebo supllementation.

Control OTHER

The combined effect of placebo supplementation and normoxia training on both performance and health at sea-level and altitude conditions.

Also known as: Placebo Juice + Normoxia training

CON: High intensity interval training (HIIT) + placebo supllementation.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Trás-os-Montes and Alto Douro: lead

Study Sites (1)

University of Trás-os-Montes e Alto-Douro

Vila Real, Portugal

Location

MeSH Terms

Conditions

Hypoxia

Interventions

Nitrates

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Nitric Acid; Nitrogen Compounds; Organic Chemicals

Study Officials

• Ana Sousa, PhD

  University of Maia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: December 11, 2024
• Study Start: February 1, 2019
• Primary Completion: July 22, 2020
• Study Completion: July 22, 2020
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)