NCT02474628

Brief Summary

Intervention studies do not account for high within-individual variation potentially compromising the magnitude of an effect. Repeat administration of a treatment allows quantification of individual responses and determination of the consistency of responses. The investigators aim to determine the consistency of metabolic and exercise responses following repeated administration of sodium bicarbonate (SB). Design and Methods: 15 physically active males will complete six cycling capacity tests at 110% of maximum power output (CCT110%) following ingestion of either 0.3 g∙kg-1Body Mass of SB (4 trials) or placebo (PL, 2 trials). Blood pH, bicarbonate, base excess and lactate will be determined at baseline, pre-exercise, post-exercise and 5-min post-exercise. Total work done (TWD) will be recorded as the exercise outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 8, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 18, 2015

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

Enrollment Period

7 months

First QC Date

June 8, 2015

Last Update Submit

June 17, 2015

Conditions

Keywords

Physiological Phenomena

Outcome Measures

Primary Outcomes (1)

  • blood pH

    5 min after a physical exercise test

Secondary Outcomes (3)

  • blood bicarbonate

    5 min after a physical exercise test

  • blood lactate

    5 min after a physical exercise test

  • anaerobic exercise capacity

    4 hours after supplementation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

0.3 g∙kg-1body mass of calcium carbonate

Dietary Supplement: calcium carbonate

Sodium bicarbonate

EXPERIMENTAL

0.3 g∙kg-1body mass of sodium bicarbonate

Dietary Supplement: sodium bicarbonate

Interventions

sodium bicarbonateDIETARY_SUPPLEMENT
Sodium bicarbonate
calcium carbonateDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • recreationally active males

You may not qualify if:

  • use of dietary supplements in the past 6 months
  • the presence of any musculoskeletal disorder
  • the use of anabolic steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508-30, Brazil

Location

Related Publications (1)

  • Froio de Araujo Dias G, da Eira Silva V, de Salles Painelli V, Sale C, Giannini Artioli G, Gualano B, Saunders B. (In)Consistencies in Responses to Sodium Bicarbonate Supplementation: A Randomised, Repeated Measures, Counterbalanced and Double-Blind Study. PLoS One. 2015 Nov 17;10(11):e0143086. doi: 10.1371/journal.pone.0143086. eCollection 2015.

MeSH Terms

Interventions

Sodium BicarbonateCalcium Carbonate

Intervention Hierarchy (Ancestors)

BicarbonatesCarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsCalcium CompoundsMinerals

Study Design

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

Study Record Dates

First Submitted

June 8, 2015

First Posted

June 18, 2015

Study Start

November 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

June 18, 2015

Record last verified: 2015-06

Locations