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

April 3, 2012
May 10, 2013
February 2012
September 2012   (final data collection date for primary outcome measure)
Time [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Time to complete 1500m
Same as current
Complete list of historical versions of study NCT01591226 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Dietary Supplements
  • Heart Rate/Drug Effects
  • Lactic Acid/Metabolism
  • Physical Education and Training/Methods
  • Wheelchairs
  • 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
  • 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: Caffeine
    6mg per kg bodyweight ingested 60min before test
    Interventions:
    • Dietary Supplement: Caffeine
    • Dietary Supplement: Sodium Chloride
  • Placebo Comparator: Placebo
    Sodium chloride and mannitol as placebo are ingested by the athlete
    Interventions:
    • Dietary Supplement: Mannitol
    • Dietary Supplement: Sodium Chloride
  • Active Comparator: Sodium Citrate
    sodium citrate diluted in 7dl water, ingestion 120 to 90min prior test
    Interventions:
    • Dietary Supplement: Sodium Citrate
    • Dietary Supplement: Mannitol
  • Active Comparator: Caffeine and Sodium Citrate
    sodium citrate 120-90min prior test capsules:60min prior test
    Interventions:
    • Dietary Supplement: Caffeine
    • Dietary Supplement: Sodium Citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
September 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • wheelchair athletes
  • national team
  • category T53 and T54

Exclusion Criteria:

  • medicated
  • pregnant (for women)
  • cardiovascular and respiratory diseases
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01591226
JF_001
No
Swiss Paraplegic Centre Nottwil
Swiss Paraplegic Centre Nottwil
Not Provided
Principal Investigator: Claudio Perret, Dr. sc. nat. Swiss Paraplegic Centre Nottwil
Swiss Paraplegic Centre Nottwil
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP