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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01835912
Other study ID # 12-009
Secondary ID
Status Completed
Phase Phase 3
First received April 10, 2013
Last updated July 23, 2014
Start date September 2012
Est. completion date April 2013

Study information

Verified date July 2014
Source Brock University
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via liver oxidation by decreasing [H+] and increasing bicarbonate concentration (HCO3-). Studies have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from active muscles. This is due to an increase in activity of the pH sensitive monocarboxylate transporter as the gradient of intracellular versus extracellular H+ increases. Therefore, artificially inducing alkalosis prior to anaerobic exercise may reduce intracellular acidosis and increase the time to fatigue - defined as a decrease in force production with an increased perception of effort. The investigators will test the null hypothesis that sodium citrate ingestion (chronic and acute) will not have an effect on exercise performance compared to placebo.


Description:

Anaerobic glycolysis quickly provides adenosine triphosphate (ATP) for muscular contraction during high intensity, short duration exercise. The fast rate of glycolysis during anaerobic exercise results in pyruvate formation exceeding pyruvate oxidation resulting in a build up of lactic acid. Lactic acid dissociates quickly to lactate (La-) and hydrogen ion (H+) which causes a decrease in muscle and blood pH. The increase in H+ causes impaired release of calcium from the sarcoplasmic reticulum and calcium ion binding which inhibits the coupling of actin and myosin.

Ingestion of sodium citrate (Na-Cit), an alkalizing agent, increases extracellular pH via liver oxidation by decreasing [H+] and increasing bicarbonate concentration (HCO3-). Studies have confirmed that increasing extracellular pH promotes the efflux of La- and H+ from active muscles. This is due to an increase in activity of the pH sensitive monocarboxylate transporter as the gradient of intracellular versus extracellular H+ increases. Therefore, artificially inducing alkalosis prior to anaerobic exercise may reduce intracellular acidosis and increase the time to fatigue - defined as a decrease in force production with an increased perception of effort. Furthermore, Cit- enters the cell through the Plasma Membrane Citrate Transporter and in the cell Cit- is involved in a number of processes: i) intermediary in the Krebs Cycle, ii) transports acetyl-Co-enzyme A (CoA)from the mitochondria to the cytosol for fatty-acid synthesis, iii) negative allosteric effector of phosphofructokinase, iv) anionic effect on membrane potential can cause a reduction in the contraction threshold.

Researchers have studied sodium bicarbonate and Na-Cit as potential alkalizing agents. Na-Cit has been studied in few sports over a broad array of doses, times, and distances with inconclusive results. McNaughton et al. researched the optimal doses and durations for Na-Cit to be potentially beneficial to performance. They concluded that 0.3-0.5g/kg, 90-120 minutes prior to maximal effort are the optimal conditions for potential ergogenic effect. The only reported side effect was gastrointestinal (GI) discomfort in a 3 of the 8 subjects. However, it seems Na-Cit is handled better than the more commonly employed sodium bicarbonate.

The investigators will test the null hypothesis that sodium citrate ingestion (chronic and acute) will not have an effect on exercise performance compared to placebo.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date April 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 13 Years to 17 Years
Eligibility Inclusion Criteria:

- Age 13-17

- Male

- Regional, provincial and national level swimmers

Exclusion Criteria:

- Females

- Level of swimming below regional level standards

- Caffeine before trials

- Chronic health concerns

- Health problems before or during the course of the trial

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)


Related Conditions & MeSH terms


Intervention

Other:
Sodium Citrate Dihydrate
Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)

Locations

Country Name City State
Canada Brock University St. Catharines Ontario

Sponsors (1)

Lead Sponsor Collaborator
Brock University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Rate of Perceived Exertion Rate of perceived exertion (RPE) was recorded after each 200 metre swimming performance
RPE scale is from 6-20. Minimum = 6 (level of exertion equal to lying down) and Maximum = 20 (maximal perceived exertion)
Numbers reported are the average of the RPE recorded for all 10 participants.
Rate of Perceived Exertion after each 200m swimming performance No
Primary Time time to complete 200 metre swimming performances in seconds
Participants chose type of swim stroke to swim a maximal effort 200 metre performance
once each 200m performance No
Secondary Lactate lactate measured at 3min post trial 3 min post performance No
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