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Blood, Muscle and Exercise Responses to Sodium Bicarbonate Supplementation

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ClinicalTrials.gov Identifier: NCT03505970
Recruitment Status : Not yet recruiting
First Posted : April 23, 2018
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE March 31, 2018
First Posted Date  ICMJE April 23, 2018
Last Update Posted Date June 6, 2019
Estimated Study Start Date  ICMJE August 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2018)
H+ transporter activity [ Time Frame: 5 minutes Post-exercise ]
Change in activity of transporters related to H+
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
H+ transporter activity [ Time Frame: 5 min Post-exercise ]
Change in activity of transporters related to H+
Change History Complete list of historical versions of study NCT03505970 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2018)
Exercise performance [ Time Frame: 1 hour Post-supplementation ]
Change in 1 km cycling time-trial performance
Original Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2018)
Exercise performance [ Time Frame: 1 h Post-supplementation ]
Change in 1 km cycling time-trial performance
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Blood, Muscle and Exercise Responses to Sodium Bicarbonate Supplementation
Official Title  ICMJE Blood and Muscle Responses to Sodium Bicarbonate Supplementation and Subsequent Exercise Performance
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Double-blind crossover
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Sports Nutritional Physiological Phenomena
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Sodium bicarbonate
    0.3 g∙kg-1body mass of sodium bicarbonate
    Intervention: Dietary Supplement: Sodium bicarbonate
  • Placebo Comparator: Placebo
    Individuals will ingest 0.3 g/kg maltodextrin before undergoing exercise
    Intervention: Dietary Supplement: Maltodextrin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2018)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Bruno Gualano, PhD 3061-8789 ext +55 gualano@usp.br
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03505970
Other Study ID Numbers  ICMJE SB_BloodMuscle
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bruno Gualano, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP