Caffeine and Sodium Citrate Ingestion

Dietary Supplements Clinical Trial

Official title:

Effects of Caffeine and Sodium Citrate Ingestion in 1500m Wheelchair Racing Athletes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591226
• Other study ID #: 2012-02
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: November 21, 2016
• Start date: February 2012
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• wheelchair athletes

• national team

• category T53 and T54

Exclusion Criteria:

• medicated

• pregnant (for women)

• cardiovascular and respiratory diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• 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
• Sodium Citrate
0.5g/kg bodyweight diluted in 7dl water ingested 120-90min prior test
• Mannitol
gelatine capsule filled with mannitol (100mg per capsule) ingested 60min prior test
• Sodium Chloride
sodium chloride diluted in 7dl water 0.045g/kg bodyweight 120-90min prior test

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	Lucerne

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time	Time to complete 1500m	3 weeks	No
Secondary	Heart Rate	Heart Rate measured from 2min before the test until 5min after the 1500m-test.	during study phase of 3 week (4 tests)	No
Secondary	Lactate Concentration	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	No
Secondary	blood pH, sodium concentration and plasma bicarbonate	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	No
Secondary	Oxygen Consumption	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	No
Secondary	rating of gastrointestinal stress	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	No
Secondary	Rating of Perceived Exertion (RPE)	15s after the end of the warm up, 15s after having completed the 1500m	during the 3 weeks of study phase	No