- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01591226
Caffeine and Sodium Citrate Ingestion
Effects of Caffeine and Sodium Citrate Ingestion in 1500m Wheelchair Racing Athletes
A positive ergogenic effect of sodium citrate and caffeine ingestion in a short-term, high-intensity exercise task was shown by several studies. These studies were conducted with healthy, able-bodied subjects.
The aim of the study is to investigate whether caffeine or sodium citrate ingestion could enhance performance in spinal cord injured wheelchair athletes. It is a double blind, placebo controlled and randomized study.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Lucerne
-
Nottwil, Lucerne, Switzerland, 6207
- Swiss Paraplegic Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- wheelchair athletes
- national team
- category T53 and T54
Exclusion Criteria:
- medicated
- pregnant (for women)
- cardiovascular and respiratory diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Caffeine
6mg per kg bodyweight ingested 60min before test
|
gelatine capsule 6mg/kg bodyweight 60min prior test
sodium chloride diluted in 7dl water 0.045g/kg bodyweight 120-90min prior test
|
|
Placebo Comparator: Placebo
Sodium chloride and mannitol as placebo are ingested by the athlete
|
sodium chloride diluted in 7dl water 0.045g/kg bodyweight 120-90min prior test
gelatine capsule filled with mannitol (100mg per capsule) ingested 60min prior test
|
|
Active Comparator: Sodium Citrate
sodium citrate diluted in 7dl water, ingestion 120 to 90min prior test
|
gelatine capsule filled with mannitol (100mg per capsule) ingested 60min prior test
0.5g/kg bodyweight diluted in 7dl water ingested 120-90min prior test
|
|
Active Comparator: Caffeine and Sodium Citrate
sodium citrate 120-90min prior test capsules:60min prior test
|
gelatine capsule 6mg/kg bodyweight 60min prior test
0.5g/kg bodyweight diluted in 7dl water ingested 120-90min prior test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time
Time Frame: 3 weeks
|
Time to complete 1500m
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: during study phase of 3 week (4 tests)
|
Heart Rate measured from 2min before the test until 5min after the 1500m-test.
|
during study phase of 3 week (4 tests)
|
|
Lactate Concentration
Time Frame: during the 3 weeks study phase
|
1min before starting the warm up, 15s after the end of the warm up, 15s after completing the test, 2min/4min/6min/8min/10min after the test
|
during the 3 weeks study phase
|
|
blood pH, sodium concentration and plasma bicarbonate
Time Frame: during the 3 weeks of study phase
|
1min before starting with the ingestion of the fluid, immediately before starting the warm up, just immediately before starting the 1500m test.
|
during the 3 weeks of study phase
|
|
Oxygen Consumption
Time Frame: during 3 weeks of study phase
|
oxygen consumption (VO2(ml/min/kg), VCO2(ml/min), RER (VCO2/VO2)) starting of the measurement is 2min before the start of the 1500m and ends 2min after having completed the 1500m
|
during 3 weeks of study phase
|
|
rating of gastrointestinal stress
Time Frame: during the 3 weeks of study phase
|
1min before starting to drink the fluid, 2min before starting with the warm up, 2min before the test and 2min after having completed the 1500m
|
during the 3 weeks of study phase
|
|
Rating of Perceived Exertion (RPE)
Time Frame: during the 3 weeks of study phase
|
15s after the end of the warm up, 15s after having completed the 1500m
|
during the 3 weeks of study phase
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claudio Perret, Dr. sc. nat., Swiss Paraplegic Centre Nottwil
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
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Natriuretic Agents
- Diuretics, Osmotic
- Diuretics
- Anticoagulants
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Chelating Agents
- Sequestering Agents
- Central Nervous System Stimulants
- Calcium Chelating Agents
- Mannitol
- Caffeine
- Citric Acid
- Sodium Citrate
Other Study ID Numbers
- 2012-02 (AP HM)
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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