- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03837886
Effects of Sodium Bicarbonate Supplementation on Intermittent and Intense Task
October 16, 2019 updated by: Fabiano Politti, University of Nove de Julho
Sodium Bicarbonate Supplementation Promotes Changes in Performance, Muscle Activity and Strength of Individuals Trained During the Performance of Intermittent and Intense Task? Randomized, Double-blind, Crossover Trial
The aim of this study was to verify if sodium bicarbonate (NaHCO3) suplementation promotes changes in the performance, muscular activity and strength of individuals trained during the intermittent and intense task .
Twelve trained adult men will participate in this randomized, double-blind, crossover clinical trial.
Each participant should receive two types of intervention with a 14-day interval between conditions: alkalosis (ALK) in which gelatinous capsules containing 0.3 g.kg -1 of NaHCO 3 and placebo (PLA) are administered, in which 0.3 g.kg-1 of Calcium Carbonate (CaCO3).
The following results will be considered: electromyographic activity (EMG) of the quadriceps muscle, peak torque, pH, lactate, and perception of effort, recovery and pain questionnaires, which will be collected during intermittent and high intensity DI protocol.
ANOVA of repeated measures will be used to verify possible differences between groups.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
12
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.
Study Locations
-
-
-
São Paulo, Brazil, 06454050
- Nove de Julho University
-
-
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
16 years to 38 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- resistance trained men (minimum 12 moths resistance training experience)
Exclusion Criteria:
- diabetes mellitus;
- respiratory (asthma, COPD), renal, metabolic, rheumatic and cardiovascular disorders;
- acid-base balance disorder;
- continuous use of some type of medication;
- use of high-protein supplementation and creatine supplementation;
- users of anabolic steroids.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Alkalosis group
The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of sodium bicarbonate
|
The subjects should ingest 0.3g.kg of sodium bicarbonate 90 minutes before the beginning of the protocol task.
|
|
Placebo Comparator: Placebo group
The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate
|
The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Electromyographic activity of the femoral quadriceps evaluated with electromyography equipment
Time Frame: 60 minutes
|
The electromyographic activity will be obtained during the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with interval of 1 minute interval between sets in an isokinetic dynamometer.
|
60 minutes
|
|
Peak torque assessed with isokinetic dynamometer equipment
Time Frame: 60 minutes
|
The peak torque will be obtained during the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with interval of 1 minute interval between sets.
|
60 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lactate assessed with portable lactometer
Time Frame: 15 seconds
|
The lactate quantification will be performed before and after the test session characterized by the execution of 10 series composed of ten repetitions of extension (concentric phase) and flexion (eccentric phase) of the knee joint, at an angular velocity of 120os-1 (radians per second), with an interval of 1 minute between sets in an isokinetic dynamometer.
|
15 seconds
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
October 20, 2019
Primary Completion (Anticipated)
October 30, 2019
Study Completion (Anticipated)
November 30, 2019
Study Registration Dates
First Submitted
February 6, 2019
First Submitted That Met QC Criteria
February 8, 2019
First Posted (Actual)
February 12, 2019
Study Record Updates
Last Update Posted (Actual)
October 17, 2019
Last Update Submitted That Met QC Criteria
October 16, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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