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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03837886
Other study ID # FP001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 20, 2019
Est. completion date November 30, 2019

Study information

Verified date October 2019
Source University of Nove de Julho
Contact Marcelo M Kalytczak, PhD
Phone 55 11 981595139
Email marcelomkal@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date November 30, 2019
Est. primary completion date October 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 42 Years
Eligibility 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 Design


Intervention

Dietary Supplement:
Sodium bicarbonate
The subjects should ingest 0.3g.kg of sodium bicarbonate 90 minutes before the beginning of the protocol task.
Calcium carbonate
The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate

Locations

Country Name City State
Brazil Nove de Julho University São Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Nove de Julho Marcelo Martins Kalytczak

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Electromyographic activity of the femoral quadriceps evaluated with electromyography equipment 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
Primary Peak torque assessed with isokinetic dynamometer equipment 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 Lactate assessed with portable lactometer 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
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