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Caffeine and Sodium Citrate Ingestion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier:
NCT01591226
First received: April 3, 2012
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention
Dietary Supplements
Heart Rate/Drug Effects
Lactic Acid/Metabolism
Physical Education and Training/Methods
Wheelchairs
 Dietary Supplement: Caffeine
Dietary Supplement: Sodium Citrate
Dietary Supplement: Mannitol
Dietary Supplement: Sodium Chloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Caffeine and Sodium Citrate Ingestion in 1500m Wheelchair Racing Athletes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Swiss Paraplegic Centre Nottwil:

Primary Outcome Measures:
  • Time [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Time to complete 1500m


Secondary Outcome Measures:
  • Heart Rate [ Time Frame: during study phase of 3 week (4 tests) ] [ Designated as safety issue: No ]
    Heart Rate measured from 2min before the test until 5min after the 1500m-test.

  • Lactate Concentration [ Time Frame: during the 3 weeks study phase ] [ Designated as safety issue: No ]
    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

  • blood pH, sodium concentration and plasma bicarbonate [ Time Frame: during the 3 weeks of study phase ] [ Designated as safety issue: No ]
    1min before starting with the ingestion of the fluid, immediately before starting the warm up, just immediately before starting the 1500m test.

  • Oxygen Consumption [ Time Frame: during 3 weeks of study phase ] [ Designated as safety issue: No ]
    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

  • rating of gastrointestinal stress [ Time Frame: during the 3 weeks of study phase ] [ Designated as safety issue: No ]
    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

  • Rating of Perceived Exertion (RPE) [ Time Frame: during the 3 weeks of study phase ] [ Designated as safety issue: No ]
    15s after the end of the warm up, 15s after having completed the 1500m


Enrollment: 9
Study Start Date: February 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Caffeine
6mg per kg bodyweight ingested 60min before test
 Dietary Supplement: Caffeine
gelatine capsule 6mg/kg bodyweight 60min prior test
Dietary Supplement: Sodium Chloride
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
 Dietary Supplement: Mannitol
gelatine capsule filled with mannitol (100mg per capsule) ingested 60min prior test
Dietary Supplement: Sodium Chloride
sodium chloride diluted in 7dl water 0.045g/kg bodyweight 120-90min prior test
Active Comparator: Sodium Citrate
sodium citrate diluted in 7dl water, ingestion 120 to 90min prior test
 Dietary Supplement: Sodium Citrate
0.5g/kg bodyweight diluted in 7dl water ingested 120-90min prior test
Dietary Supplement: Mannitol
gelatine capsule filled with mannitol (100mg per capsule) ingested 60min prior test
Active Comparator: Caffeine and Sodium Citrate
sodium citrate 120-90min prior test capsules:60min prior test
 Dietary Supplement: Caffeine
gelatine capsule 6mg/kg bodyweight 60min prior test
Dietary Supplement: Sodium Citrate
0.5g/kg bodyweight diluted in 7dl water ingested 120-90min prior test

Detailed Description:

The athletes have to complete four 1500m tests on a training roller. Before each treatment they get different supplementations. Once they get sodium citrate and a placebo, once caffeine and a placebo, once sodium citrate and caffeine and for the fourth treatment they get twice a placebo. Two hours after starting with the supplementation they have to complete the 1500m as fast as possible. Time to complete 1500m, blood pH, plasma bicarbonate, sodium concentration, heart rate, oxygen consumption, blood lactate concentration and rate of perceived exertion (RPE) were measured.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • wheelchair athletes
  • national team
  • category T53 and T54

Exclusion Criteria:

  • medicated
  • pregnant (for women)
  • cardiovascular and respiratory diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591226

Locations
Switzerland
Swiss Paraplegic Centre
Nottwil, Lucerne, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Claudio Perret, Dr. sc. nat. Swiss Paraplegic Centre Nottwil
  More Information

No publications provided

Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01591226     History of Changes
Other Study ID Numbers: JF_001
Study First Received: April 3, 2012
Last Updated: May 10, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Paraplegic Centre Nottwil:
caffeine
sodium citrate
exercise performance
wheelchair athletes
1500m

Additional relevant MeSH terms:
Caffeine
Citric Acid
Mannitol
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Anticoagulants
Hematologic Agents
Chelating Agents
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013