- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01835912
Chronic Versus Acute Dosing of Sodium Citrate for Swimming 200m
Chronic vs. Acute Ingestion of Sodium Citrate: a Randomised Placebo Controlled Cross-over Trial for Swimming a 200 Metres in Well-trained Swimmers Age 13-17
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Ontario
-
St. Catharines, Ontario, Canada, L2S3A1
- Brock University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Flavoured water placebo for acute dosing
500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
|
Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
Other Names:
|
|
Experimental: Sodium Citrate Dihydrate Acute
dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water
|
Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
Other Names:
|
|
Placebo Comparator: Flavoured water placebo chronic dosing
500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
|
Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
Other Names:
|
|
Experimental: Sodium Citrate Dihydrate Chronic
3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water
|
Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time
Time Frame: once each 200m performance
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lactate
Time Frame: 3 min post performance
|
lactate measured at 3min post trial
|
3 min post performance
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Perceived Exertion
Time Frame: Rate of Perceived Exertion after each 200m swimming performance
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nota Klentrou, PhD, Brock University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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