Impact of NaHCO3- on Exercise Hyperpnea

NCT03057535 | Completed Early Phase 1

• 1 other identifier: A02-M19-15B
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

An abnormally high V̇E/V̇CO2 response to exercise is a key pathophysiological feature of patients with chronic cardiopulmonary disease that is associated with adverse health outcomes. It follows that any intervention capable of decreasing the V̇E/V̇CO2 response to exercise has the potential to improve clinical and/or patient-reported outcomes. The investigators of this trial will compare the effects of orally administered sodium chloride (4 g, placebo) and sodium bicarbonate (0.3 g/kg of body mass) on ventilation, breathing pattern, dynamic operating lung volume, gas exhange, cardiovascular, metabolic and symptom parameters during symptom-limited, high-intensity, constant-work-rate cycle exercise testing in healthy adults aged 20-40 years.

Conditions

Pulmonary Ventilation

Keywords

Exercise; Sodium Bicarbonate; Ventilatory equivalent for carbon dioxide

Outcome Measures

Primary Outcomes (1)

• Ventilatory equivalent to carbon dioxide (V̇E/V̇CO2) at its lowest point ("nadir") during exercise

  The V̇E/V̇CO2 nadir will be identified as the lowest 30-sec average data point during constant-load cycle exercise testing

  Participants will be followed until all study visits are complete, an expected average of 3 weeks

Secondary Outcomes (1)

• Partial pressure of carbon dioxide in the arterialized capillary blood (PacCO2)

  Time Frame: Participants will be followed until all study visits are complete, an expected average of 3 weeks

Study Arms (2)

Sodium Bicarbonate

EXPERIMENTAL

Ingestion of sodium bicarbonate (0.3 g/kg of body mass)

Drug: Sodium Bicarbonate

Sodium Chloride

PLACEBO COMPARATOR

Ingestion of sodium chloride (4 g)

Drug: Sodium Chloride

Interventions

Sodium Bicarbonate DRUG

Sodium Bicarbonate

Sodium Chloride DRUG

Sodium Chloride

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Non-smoking
• Habitually active
• Non-obese (Body Mass Index \<30 kg/m2)
• Normal lung function on spirometry

You may not qualify if:

• Self-reported gastrointestinal, cardiovascular, vascular, respiratory, kidney, liver, musculoskeletal, endocrine, neuromuscular and/or metabolic disease/dysfunction
• Taking doctor prescribed medications other than oral contraceptives

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McGill University, Department of Kinesiology & Physical Education, Clinical Exercise & Respiratory Physiology Laboratory

Montreal, Quebec, H2W 1S4, Canada

Location

Related Links

• Clinical Exercise \& Respiratory Physiology Laboratory (CERPL) of McGill University

MeSH Terms

Conditions

Motor Activity

Interventions

Sodium Bicarbonate; Sodium Chloride

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds

Study Officials

• Dennis Jensen, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 20, 2017
• Study Start: May 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 20, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)