Blood, Muscle and Exercise Responses to Sodium Bicarbonat... | NCT03505970

Studies
Blood, Muscle and Exercise Responses to Sodium Bicarbonate Supplementation

NCT03505970

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Jun 6, 2019Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Sports Nutritional Physiological Phenomena

Interventions

Sodium bicarbonate
Maltodextrin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2019Estimated

Primary Completion Date

Nov 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Mar 31, 2018

First Submission Date that Met QC Criteria

Apr 13, 2018

First Posted Date

Apr 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 4, 2019

Last Update Posted Date

Jun 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sodium bicarbonate	Experimental	0.3 g∙kg-1body mass of sodium bicarbonate	Dietary Supplement: Sodium bicarbonate
Placebo	Placebo Comparator	Individuals will ingest 0.3 g/kg maltodextrin before undergoing exercise	Dietary Supplement: Maltodextrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium bicarbonate	Dietary Supplement	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
H+ transporter activity	Change in activity of transporters related to H+	5 minutes Post-exercise

Secondary Outcomes

Measure	Description	Time Frame
Exercise performance	Change in 1 km cycling time-trial performance	1 hour Post-supplementation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bruno Gualano, PhD	Contact	3061-8789	+55	gualano@usp.br

Overall Officials

Not provided

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017693	Sodium Bicarbonate
C008315	maltodextrin

Ancestor Terms

ID	Term
D001639	Bicarbonates
D002254	Carbonates
D002255	Carbonic Acid
D017554	Carbon Compounds, Inorganic

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Browse Branches

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