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Trial registered on ANZCTR

Registration number

ACTRN12610001057077

Ethics application status

Approved

Date submitted

9/09/2008

Date registered

1/12/2010

Date last updated

1/12/2010

Type of registration

Retrospectively registered

Titles & IDs

Public title

Rehydration with Intravenous Fluid and Oral Glycerol in Athletes: Effects on Cardiovascular, Hormonal, Thermoregulatory, Metabolic and Performance Variables

Scientific title

In athletes, is intravenous fluid with oral glycerol comparable to either intervention alone or placebo, for rehydration

Secondary ID [1]

HMS06/2303/4

Universal Trial Number (UTN)

U1111-1118-3236

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dehydration

Condition category

Condition code

Other

Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All subjects completed all four experimental trials in a randomised crossover sequence: (1) 100% oral fluid without glycerol (oral); (2) 100% oral fluid with oral glycerol (oral with glycerol); (3) 50% oral fluid, 50% intravenous (IV) fluid (0.9% NaCl), without glycerol (IV); and (4) 50% oral fluid, 50% intravenous fluid (0.9% NaCl) with oral glycerol (IV with oral glycerol). Trials were conducted at least two weeks apart.

In each experimental trial, subjects were initially dehydrated via cycling exercise in the heat (35oC, 70% relative humidity) to -4% bodyweight. The interventions (oral [control trial], oral with glycerol, IV and IV with oral glycerol) were then provided during rehydration over a two hour period. The total volume of rehydration was 150% of the bodyweight lost. In the first hour, subjects were given 100% of the bodyweight lost, with a further 50% provided in the second hour of rehydration.

Glycerol (1.5 g/kg bodyweight) was provided orally in a sports drink (Gatorade) solution during two hours of rehydration (after being dehydrated by -4% bodyweight) in the oral with glycerol and IV with glycerol trials. The overall dose was provided in two fluid boluses containing 1.0 g/kg and 0.5 g/kg during the first and second hours of rehydration, respectively.

Intravenous fluids (0.9% NaCl) were administered in the IV and IV with oral glycerol trials. In these trials, half the rehydration volume was IV fluid and the other half was oral fluid.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Water and sports drink (Gatorade) are provided in combination as the control/placebo (oral) rehydration condition.

Subjects were initially dehydrated via cycling exercise in the heat (35oC, 70% relative humidity) to -4% bodyweight. The placebo solutions (water and Gatorade) were then provided during rehydration over a two hour period. The total volume of rehydration was 150% of the bodyweight lost. In the first hour, subjects were given 100% of the bodyweight lost, with a further 50% provided in the second hour of rehydration.

Intravenous fluids were only provided in the IV and IV with oral glycerol trials)

Control group

Placebo

Outcomes

Primary outcome [1]

Change in plasma volume (measured using changes to heamoglobin/heamatocrit and Dill and Costal equations) to monitor hydration status.

Timepoint [1]

Pre-dehydration, -1% bodyweight, -2% bodyweight, -3% bodyweight, post-dehydration, post-first hour of rehydration, mid-second hour of rehydration, post-second hour of rehydration, mid-equilibration, post-equilibration and following 15 min, 30 min, 10 km, 20 km, 30 km and 40 km of an exercise performance test.

Primary outcome [2]

Exercise performance assessed as time to complete a 40 km time trial.

Timepoint [2]

Following 10 km, 20 km, 30 km and 40 km of a 40 km time trial.

Secondary outcome [1]

Change in aldosterone concentration (measured using a high-performance liquid chromatography-tandem mass spectrometric method) to reflect hydration status.

Timepoint [1]

Pre-dehydration, -1% bodyweight, -2% bodyweight, -3% bodyweight, post-dehydration, post-first hour of rehydration, mid-second hour of rehydration, post-second hour of rehydration, mid-equilibration, post-equilibration and following 30 min, 20 km and 40 km of an exercise performance test.

Secondary outcome [2]

Change in cortisol concentration (measured using a high-performance liquid chromatography-tandem mass spectrometric method) to reflect stress response.

Timepoint [2]

Pre-dehydration, -1% bodyweight, -2% bodyweight, -3% bodyweight, post-dehydration, post-first hour of rehydration, mid-second hour of rehydration, post-second hour of rehydration, mid-equilibration, post-equilibration and following 30 min, 20 km and 40 km of an exercise performance test.

Secondary outcome [3]

Plasma osmolality (measured using vapour pressure osmometer)

Timepoint [3]

Eligibility

Key inclusion criteria

1) male aged 18 – 40 yrs;
2) experienced cyclist;
3) high endurance training status (V•O2max > 55 mL · kg-1 · min-1); and
4) consistently high training volumes for at least the preceding two months

Minimum age

18 Years

Maximum age

40 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

1) a history of current or previous renal, hepatic, cardiovascular, thermoregulatory or endocrine disorders;
2) contraindications to exercising in the heat;
3) any current or chronic health problems or injuries;
4) the use of any diuretic during the preceding four weeks; and
5) having made a blood donation in the preceding three months

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

30/09/2008

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

4067

Recruitment postcode(s) [2]

4068

Recruitment postcode(s) [3]

4064

Recruitment postcode(s) [4]

4103

Recruitment postcode(s) [5]

4121

Recruitment postcode(s) [6]

4520

Recruitment postcode(s) [7]

4072

Recruitment postcode(s) [8]

4113

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Queensland

Address [1]

School of Human Movement Studies
Blair Dr, St Lucia Campus
Brisbane
QLD 4072

Country [1]

Australia

Primary sponsor type

University

Name

University of Queensland

Address

School of Human Movement Studies
Blair Dr, St Lucia Campus
Brisbane
QLD 4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Government body

Name [1]

Queensland Academy of Sport

Address [1]

Queensland Sport and Athletics Centre (QSAC)
Kessels Road
Nathan QLD 4111

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Queensland Medical Research Ethics Committee

Ethics committee address [1]

University of Queensland Medical Research Ethics Committee
St Lucia Campus
Cumbrae Stewart Building
The University of Queensland
ST. LUCIA QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

23/02/2006

Ethics approval number [1]

HMS06/2303/4

Summary

Brief summary

The major aim of this study is to assess whether rehydration in athletes can be improved by the use of intravenous fluids and/or oral glycerol, compared to oral fluids alone. It was hypothesised that both intravenous fluids or oral glycerol would improve rehydration, but that a combination of intravenous fluids and oral glycerol together would improve rehydration more than either of the interventions alone.

Trial website

Trial related presentations / publications

Presentations:
1.	van Rosendal SP, Strobel NA, Osborne MA, and Coombes JS. (2008) The effect of intravenous fluid and oral glycerol on rehydration and exercise performance in a hot/humid environment. ACSMS: Sports Medicine Australia National Conference, 16th-18th October, Hamilton Island Aus, 2008. Personal funding.

2.	van Rosendal, S.P. Rehydration techniques for subsequent endurance performance in a hot/humid environment: The effect of glycerol and IV fluid. Griffith University Seminar Series: Invited speaker, Griffith University, Gold Coast 2008. No funding required.

3.	van Rosendal SP, Strobel NA, Osborne MA, and Coombes JS. The effect of intravenous fluid and oral glycerol on rehydration and exercise performance in a hot/humid environment. Annual Human Movement Studies Postgraduate Conference, Gold Coast, 2008. Funding School of Human Movement Studies and personal.

4.	van Rosendal, S.P., Natalie A. Strobel, Mark A. Osborne, and Jeff S. Coombes. (2008) The effect of glycerol on IV and oral rehydration techniques and subsequent endurance performance in a hot/humid environment. Annual Renal Research Meeting, Royal Brisbane Hospital, 2008. Personal funding.

5.	van Rosendal, S.P., Ward, L.C., Osborne, M.A. and Coombes, J.S. Measuring and Optimising Rehydration. DSO Singapore Military Laboratories and Singapore Sports Council seminar series: Invited speaker, Singapore, 2008. Funding UQ Graduate School Research Travel Grant (GSRTG).

Publications - journal articles:
Taylor, P.J., van Rosendal, S.P., Coombes, J.S., Gordon, R. and Stowasser, M. Simultaneous measurement of aldosterone and cortisol by high-performance liquid chromatography-tandem mass spectrometry: application to dehydration-rehydration studies. J Chromatogr B Analyt Technol Biomed Life Sci. 2010;878(15-16):1195-8.

Publications - published abstracts:
1. van Rosendal SP, Strobel NA, Osborne MA, and Coombes JS. The effect of intravenous fluid and oral glycerol on rehydration and exercise performance in a hot/humid environment. ACSMS: Sports Medicine Australia National Conference, 16th-18th October, Hamilton Island Aus, 2008.

2. van Rosendal SP, Ward LC, and Coombes JS. (2008). Skin and subcutaneous water content as indices of dehydration. 8th International Symposium on In vivo body composition studies, 9th-12th July 2008, New York, USA. Int J Body Comp Res 6: 72.

3. van Rosendal SP, Strobel NA, Osborne MA, and Coombes JS. (2008). The effect of intravenous fluid and oral glycerol on rehydration and exercise performance in a hot/humid environment. Annual Human Movement Studies Postgraduate Conference, Gold Coast, 2008.

4. Paul J. Taylor, Simon van Rosendal, Jeff S. Coombes, Richard Gordon, Michael Stowasser. (2009). Simultaneous Measurement of Aldosterone and Cortisol in Plasma by HPLC-Tandem Mass Spectrometry: Application to Sports Medicine Studies. 11th International Congress of Therapeutic Drug Monitoring & Clinical Toxicology, Montréal, Québec, Canada, 2009.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Simon van Rosendal

Address

School of Human Movement Studies
University of Queensland
Blair Dr, St Lucia Campus
Brisbane
QLD 4072

Country

Australia

Phone

+61 421856932

Fax

simon.vanrosendal@uqconnect.edu.au

Contact person for scientific queries

Name

Gary Wilson

Address

School of Human Movement Studies
University of Queensland
Blair Dr, St Lucia Campus
Brisbane
QLD 4072

Country

Australia

Phone

+61 7 3365 6445

Fax

gwilson@hms.uq.edu.au

No information has been provided regarding IPD availability

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No Supporting Document Provided

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