NCT03837886

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

October 20, 2019

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

October 17, 2019

Status Verified

October 1, 2019

Enrollment Period

10 days

First QC Date

February 6, 2019

Last Update Submit

October 16, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Lactate assessed with portable lactometer

    15 seconds

Study Arms (2)

Alkalosis group

EXPERIMENTAL

The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of sodium bicarbonate

Dietary Supplement: Sodium bicarbonate

Placebo group

PLACEBO COMPARATOR

The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate

Dietary Supplement: Calcium carbonate

Interventions

Sodium bicarbonateDIETARY_SUPPLEMENT

The subjects should ingest 0.3g.kg of sodium bicarbonate 90 minutes before the beginning of the protocol task.

Alkalosis group
Calcium carbonateDIETARY_SUPPLEMENT

The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate

Placebo group

Eligibility Criteria

Age20 Years - 42 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • resistance trained men (minimum 12 moths resistance training experience)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nove de Julho University

São Paulo, 06454050, Brazil

Location

MeSH Terms

Conditions

AlkalosisFatigue

Interventions

Sodium BicarbonateCalcium Carbonate

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsCalcium CompoundsMinerals

Central Study Contacts

Marcelo M Kalytczak, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2019

First Posted

February 12, 2019

Study Start

October 20, 2019

Primary Completion

October 30, 2019

Study Completion

November 30, 2019

Last Updated

October 17, 2019

Record last verified: 2019-10

Locations