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Caffeine and Sodium Citrate Ingestion

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ClinicalTrials.gov Identifier: NCT01591226
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

Tracking Information
First Submitted Date  ICMJE April 3, 2012
First Posted Date  ICMJE May 3, 2012
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE February 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
Time [ Time Frame: 3 weeks ]
Time to complete 1500m
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01591226 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2012)
  • 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.
  • 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
  • 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.
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caffeine and Sodium Citrate Ingestion
Official Title  ICMJE Effects of Caffeine and Sodium Citrate Ingestion in 1500m Wheelchair Racing Athletes
Brief Summary

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dietary Supplements
  • Heart Rate/Drug Effects
  • Lactic Acid/Metabolism
  • Physical Education and Training/Methods
  • Wheelchairs
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2013)
9
Original Estimated Enrollment  ICMJE
 (submitted: May 1, 2012)
12
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • wheelchair athletes
  • national team
  • category T53 and T54

Exclusion Criteria:

  • medicated
  • pregnant (for women)
  • cardiovascular and respiratory diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01591226
Other Study ID Numbers  ICMJE 2012-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Swiss Paraplegic Centre Nottwil
Study Sponsor  ICMJE Swiss Paraplegic Centre Nottwil
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Claudio Perret, Dr. sc. nat. Swiss Paraplegic Centre Nottwil
PRS Account Swiss Paraplegic Centre Nottwil
Verification Date November 2016

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