Dietary SupplementsNCT01591226
Caffeine and Sodium Citrate Ingestion
A study testing Caffeine, Sodium Citrate and Mannitol in people with Dietary Supplements and Heart Rate/Drug Effects, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplements, Heart Rate/Drug Effects, Lactic Acid/Metabolism
- What is being tested?
- Caffeine, Sodium Citrate and Mannitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2012to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- wheelchair athletes
- national team
- category T53 and T54
Who cannot join
- medicated
- pregnant (for women)
- cardiovascular and respiratory diseases
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: 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.
Read the 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.
- Conditions
- Dietary Supplements, Heart Rate/Drug Effects, Lactic Acid/Metabolism, Physical Education and Training/Methods, Wheelchairs
- Being tested
- Caffeine, Sodium Citrate, Mannitol, Sodium Chloride
- Keywords
- caffeine, sodium citrate, exercise performance, wheelchair athletes, 1500m
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDietary supplement
gelatine capsule 6mg/kg bodyweight 60min prior test
Sodium CitrateDietary supplement
0.5g/kg bodyweight diluted in 7dl water ingested 120-90min prior test
MannitolDietary supplement
gelatine capsule filled with mannitol (100mg per capsule) ingested 60min prior test
Sodium ChlorideDietary supplement
sodium chloride diluted in 7dl water 0.045g/kg bodyweight 120-90min prior test
| Study group | Role | What they receive |
|---|---|---|
| Caffeine | Active comparator | 6mg per kg bodyweight ingested 60min before test Receives: Dietary Supplement: Caffeine; Dietary Supplement: Sodium Chloride |
| Placebo | Placebo comparator | Sodium chloride and mannitol as placebo are ingested by the athlete Receives: Dietary Supplement: Mannitol; Dietary Supplement: Sodium Chloride |
| Sodium Citrate | Active comparator | sodium citrate diluted in 7dl water, ingestion 120 to 90min prior test Receives: Dietary Supplement: Sodium Citrate; Dietary Supplement: Mannitol |
| Caffeine and Sodium Citrate | Active comparator | sodium citrate 120-90min prior test capsules:60min prior test Receives: Dietary Supplement: Caffeine; Dietary Supplement: Sodium Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time
Time to complete 1500m
Measured: 3 weeks
Secondary outcomes (6)
Heart Rate
Heart Rate measured from 2min before the test until 5min after the 1500m-test.
Measured: during study phase of 3 week (4 tests)
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
Measured: during the 3 weeks study phase
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.
Measured: during the 3 weeks of study phase
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
Measured: during 3 weeks of study phase
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
Measured: during the 3 weeks of study phase
Rating of Perceived Exertion (RPE)
15s after the end of the warm up, 15s after having completed the 1500m
Measured: during the 3 weeks of study phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Claudio Perret, Dr. sc. nat., Principal investigator, Swiss Paraplegic Research, Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591226
- Sponsor's protocol ID
- 2012-02
- Status last verified
- Nov 2016
- First submitted
- 3 Apr 2012
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Caffeine and Sodium Citrate Ingestion in 1500m Wheelchair Racing Athletes
- ClinicalTrials.gov ID
- NCT01591226
- Acronym / sponsor ID
- 2012-02
- Conditions
- Dietary Supplements, Heart Rate/Drug Effects, Lactic Acid/Metabolism, Physical Education and Training/Methods, Wheelchairs
- Keywords
- caffeine, sodium citrate, exercise performance, wheelchair athletes, 1500m
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caffeine | Active comparator | Dietary Supplement: Caffeine, Dietary Supplement: Sodium Chloride6mg per kg bodyweight ingested 60min before test |
| Placebo | Placebo comparator | Dietary Supplement: Mannitol, Dietary Supplement: Sodium ChlorideSodium chloride and mannitol as placebo are ingested by the athlete |
| Sodium Citrate | Active comparator | Dietary Supplement: Sodium Citrate, Dietary Supplement: Mannitolsodium citrate diluted in 7dl water, ingestion 120 to 90min prior test |
| Caffeine and Sodium Citrate | Active comparator | Dietary Supplement: Caffeine, Dietary Supplement: Sodium Citratesodium citrate 120-90min prior test capsules:60min prior test |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- wheelchair athletes
- national team
- category T53 and T54
Key exclusion criteria (3 listed)
- medicated
- pregnant (for women)
- cardiovascular and respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeinegelatine capsule 6mg/kg bodyweight 60min prior test | Dietary supplement | Caffeine, Caffeine and Sodium Citrate |
| Sodium Citrate0.5g/kg bodyweight diluted in 7dl water ingested 120-90min prior test | Dietary supplement | Caffeine and Sodium Citrate, Sodium Citrate |
| Mannitolgelatine capsule filled with mannitol (100mg per capsule) ingested 60min prior test | Dietary supplement | Placebo, Sodium Citrate |
| Sodium Chloridesodium chloride diluted in 7dl water 0.045g/kg bodyweight 120-90min prior test | Dietary supplement | Caffeine, Placebo |
Primary outcome
Time
Time frame: 3 weeks
Time to complete 1500m
6 secondary outcomes
Heart Rate
Time frame: during study phase of 3 week (4 tests)
Lactate Concentration
Time frame: during the 3 weeks study phase
blood pH, sodium concentration and plasma bicarbonate
Time frame: during the 3 weeks of study phase
Oxygen Consumption
Time frame: during 3 weeks of study phase
rating of gastrointestinal stress
Time frame: during the 3 weeks of study phase
Rating of Perceived Exertion (RPE)
Time frame: during the 3 weeks of study phase
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Perret, Dr. sc. nat. principal investigator
Swiss Paraplegic Research, Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine, Sodium Citrate and Mannitol in people with Dietary Supplements and Heart Rate/Drug Effects, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016.