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Blood, Muscle and Exercise Responses to Sodium Bicarbonate Supplementation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03505970
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : June 6, 2019
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Sports Nutritional Physiological Phenomena Dietary Supplement: Sodium bicarbonate Dietary Supplement: Maltodextrin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Double-blind crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Blood and Muscle Responses to Sodium Bicarbonate Supplementation and Subsequent Exercise Performance
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sodium bicarbonate
0.3 g∙kg-1body mass of sodium bicarbonate
Dietary Supplement: 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
Dietary Supplement: Maltodextrin
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.

Primary Outcome Measures :
  1. H+ transporter activity [ Time Frame: 5 minutes Post-exercise ]
    Change in activity of transporters related to H+

Secondary Outcome Measures :
  1. Exercise performance [ Time Frame: 1 hour Post-supplementation ]
    Change in 1 km cycling time-trial performance

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03505970

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Contact: Bruno Gualano, PhD 3061-8789 ext +55

Sponsors and Collaborators
University of Sao Paulo

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Responsible Party: Bruno Gualano, Professor, University of Sao Paulo Identifier: NCT03505970    
Other Study ID Numbers: SB_BloodMuscle
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bruno Gualano, University of Sao Paulo:
Physiological Phenomena