Caffeine and Sodium Citrate Ingestion

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

Tracking Information

• First Submitted Date: April 3, 2012
• First Posted Date: May 3, 2012
• Last Update Posted Date: November 22, 2016
• Study Start Date: February 2012
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 1, 2012)

Time [ Time Frame: 3 weeks ]

Time to complete 1500m

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01591226 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Caffeine and Sodium Citrate Ingestion
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Dietary Supplements
• Heart Rate/Drug Effects
• Lactic Acid/Metabolism
• Physical Education and Training/Methods
• Wheelchairs

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 10, 2013): 9
• Original Estimated Enrollment (submitted: May 1, 2012): 12
• Actual Study Completion Date: September 2012
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• wheelchair athletes
• national team
• category T53 and T54

Exclusion Criteria:

• medicated
• pregnant (for women)
• cardiovascular and respiratory diseases

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT01591226
• Other Study ID Numbers: 2012-02
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Swiss Paraplegic Centre Nottwil
• Study Sponsor: Swiss Paraplegic Centre Nottwil
• Collaborators: Not Provided

Investigators

• Principal Investigator: Claudio Perret, Dr. sc. nat.; Swiss Paraplegic Centre Nottwil

• PRS Account: Swiss Paraplegic Centre Nottwil
• Verification Date: November 2016