- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03505970
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
Status
Unknown
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
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.
Clinical Trials on Sports Nutritional Physiological Phenomena
-
University of Sao PauloCompletedSports Nutritional Physiological Phenomena
-
University of Sao PauloCompleted
-
Maastricht University Medical CenterCompletedBlood Pressure | Nutritional Physiological PhenomenaNetherlands
-
NestléCompletedInfant Formula | Infant Nutritional Physiological PhenomenaSaudi Arabia
-
TNOCharles University, Czech Republic; University of Oslo; Lund University; Universitaire... and other collaboratorsActive, not recruitingBiological Markers | Health | Nutritional Physiological PhenomenaIreland, Denmark, Finland, Austria, United Kingdom, Belgium, Czechia, France, Italy, Netherlands, Spain, Switzerland
-
Medical University of ViennaCompletedRespiratory Physiological PhenomenaAustria
-
Academia Española de Nutrición y DietéticaLIDL EspañaCompletedComplementary Feeding | Infant Nutritional Physiological PhenomenaSpain
-
Hospital Privado de Comunidad de Mar del PlataCompletedRespiratory Physiological PhenomenaArgentina
-
University of ParmaCollegio Italiano di Osteopatia; Foundation COME CollaborationCompletedCardiovascular Physiological PhenomenaItaly
-
Seoul National University HospitalKorea Advanced Institute of Science and TechnologyCompleted
Clinical Trials on Sodium bicarbonate
-
Sheba Medical CenterUnknownExtravasation | InfiltrationIsrael
-
HALEONCompletedGingivitisUnited Kingdom
-
GlaxoSmithKlineCompleted
-
Guy's and St Thomas' NHS Foundation TrustUniversity of PittsburghActive, not recruiting
-
Jennifer Gassman, PhDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); The...CompletedChronic Kidney DiseaseUnited States
-
Wake Forest University Health SciencesCompletedRenal Replacement Therapy | Kidney Failure, AcuteUnited States
-
University of UtahThe University of Utah Center on AgingTerminatedChronic Kidney DiseaseUnited States
-
Kaiser PermanenteCompletedKidney Diseases | Contrast Induced NephropathyUnited States
-
Instituto Nacional de Cardiologia Ignacio ChavezUnknownAcute Kidney FailureMexico
-
Erasmus Medical CenterCompletedChronic Kidney DiseaseNetherlands