Blood, Muscle and Exercise Responses to Sodium Bicarbonate Supplementation

June 4, 2019 updated by: Bruno Gualano, University of Sao Paulo

Blood and Muscle Responses to Sodium Bicarbonate Supplementation and Subsequent Exercise Performance

The aim of this study is to evaluate the changes in activity of transporters of H+ (monocarboxylate transporters; MCT1, MCT4, NHE) following sodium bicarbonate supplementation and subsequent exercise performance. Fifteen healthy men (age 18-35 years) will be invited to attend the laboratory on five separate visits to a randomized, double-blind, placebo-controlled study. Participants will be supplemented with a 0.3 g/kg dose of sodium bicarbonate or placebo (Analytical Pharmacy, Brazil) in opaque gelatin capsules. One hour after supplementation they will perform a 1-km time trial and every 10 minutes a blood sample will be collected. A muscle biopsy will be taken prior to supplementation, immediately prior to exercise, and immediately post-exercise. A questionnaire will be also used to evaluate the side-effects associated with sodium bicarbonate supplementation. Muscle and blood samples will be analysed for acidity and H+ and muscle samples will be analysed for H+ transporters (MCT1, MCT4, NHE).

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • 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.

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

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy males

Exclusion Criteria:

  • Smokers
  • Chronic disease
  • Prior or current use of steroids
  • Use of creatine in the last 6 months
  • Use of beta-alanine in the last 6 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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium bicarbonate
0.3 g∙kg-1body mass of sodium bicarbonate
Sodium bicarbonate in powder form ingested in gelatine capsules. This leads to an increase bicarbonate concentration in blood, increasing buffering capacity which may lead to improvements in exercise
Placebo Comparator: Placebo
Individuals will ingest 0.3 g/kg maltodextrin before undergoing exercise
Maltodextrin will be used as a placebo as it will not lead to any increases in circulating bicarbonate and, at this dose, will not likely have any physiological effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H+ transporter activity
Time Frame: 5 minutes Post-exercise
Change in activity of transporters related to H+
5 minutes Post-exercise

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise performance
Time Frame: 1 hour Post-supplementation
Change in 1 km cycling time-trial performance
1 hour Post-supplementation

Collaborators and Investigators

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

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 (Anticipated)

August 1, 2019

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

March 31, 2018

First Submitted That Met QC Criteria

April 13, 2018

First Posted (Actual)

April 23, 2018

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • SB_BloodMuscle

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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