NCT03505970

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).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

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

March 31, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 23, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 6, 2019

Status Verified

June 1, 2019

Enrollment Period

1.3 years

First QC Date

March 31, 2018

Last Update Submit

June 4, 2019

Conditions

Keywords

Physiological Phenomena

Outcome Measures

Primary Outcomes (1)

  • H+ transporter activity

    Change in activity of transporters related to H+

    5 minutes Post-exercise

Secondary Outcomes (1)

  • Exercise performance

    1 hour Post-supplementation

Study Arms (2)

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

Sodium bicarbonateDIETARY_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

Sodium bicarbonate
MaltodextrinDIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sodium Bicarbonatemaltodextrin

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium Compounds

Central Study Contacts

Bruno Gualano, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Double-blind crossover
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2018

First Posted

April 23, 2018

Study Start

August 1, 2019

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

June 6, 2019

Record last verified: 2019-06