NCT01591226

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

7 months

First QC Date

April 3, 2012

Last Update Submit

November 21, 2016

Conditions

Keywords

caffeinesodium citrateexercise performancewheelchair athletes1500m

Outcome Measures

Primary Outcomes (1)

  • Time

    Time to complete 1500m

    3 weeks

Secondary Outcomes (6)

  • Heart Rate

    during study phase of 3 week (4 tests)

  • Lactate Concentration

    during the 3 weeks study phase

  • blood pH, sodium concentration and plasma bicarbonate

    during the 3 weeks of study phase

  • Oxygen Consumption

    during 3 weeks of study phase

  • rating of gastrointestinal stress

    during the 3 weeks of study phase

  • +1 more secondary outcomes

Study Arms (4)

Caffeine

ACTIVE COMPARATOR

6mg per kg bodyweight ingested 60min before test

Dietary Supplement: CaffeineDietary Supplement: Sodium Chloride

Placebo

PLACEBO COMPARATOR

Sodium chloride and mannitol as placebo are ingested by the athlete

Dietary Supplement: MannitolDietary Supplement: Sodium Chloride

Sodium Citrate

ACTIVE COMPARATOR

sodium citrate diluted in 7dl water, ingestion 120 to 90min prior test

Dietary Supplement: Sodium CitrateDietary Supplement: Mannitol

Caffeine and Sodium Citrate

ACTIVE COMPARATOR

sodium citrate 120-90min prior test capsules:60min prior test

Dietary Supplement: CaffeineDietary Supplement: Sodium Citrate

Interventions

CaffeineDIETARY_SUPPLEMENT

gelatine capsule 6mg/kg bodyweight 60min prior test

CaffeineCaffeine and Sodium Citrate
Sodium CitrateDIETARY_SUPPLEMENT

0.5g/kg bodyweight diluted in 7dl water ingested 120-90min prior test

Caffeine and Sodium CitrateSodium Citrate
MannitolDIETARY_SUPPLEMENT

gelatine capsule filled with mannitol (100mg per capsule) ingested 60min prior test

PlaceboSodium Citrate
Sodium ChlorideDIETARY_SUPPLEMENT

sodium chloride diluted in 7dl water 0.045g/kg bodyweight 120-90min prior test

CaffeinePlacebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • wheelchair athletes
  • national team
  • category T53 and T54

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Interventions

CaffeineSodium CitrateMannitolSodium Chloride

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCitric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsSugar AlcoholsAlcoholsCarbohydratesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Claudio Perret, Dr. sc. nat.

    Swiss Paraplegic Research, Nottwil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2012

First Posted

May 3, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations