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DehydrationAPEXNCT01893853

Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study)

A study testing Exercise Intervention in people with Dehydration, run by Pennington Biomedical Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the APEX study is to determine whether carbohydrate-electrolyte beverage intake promotes fluid balance during exercise in the heat compared with water or placebo intake. Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Dehydration
What is being tested?
Exercise Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
Oct 2012to Oct 2013
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 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Males aged 18-35 years
  • Healthy (No uncontrolled disease)

Who cannot join

  • No medications that influence fluid balance
  • No uncontrolled disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

About this study

The purpose of the APEX study is to determine whether carbohydrate-electrolyte beverage intake promotes fluid balance during exercise in the heat compared with water or placebo intake.

Read the detailed description

Exercise in the heat has large effects on cardiovascular strain, the ability to regulate core body temperature, and performance because of an increase in the reliance on body fluid distribution to the skin to maintain adequate sweat rates and heat dissipation. Carbohydrate-electrolyte beverage intake during exercise in the heat may improve fluid balance and subsequent physical performance.

The participants will be assigned each arm in a randomized, counterbalanced, cross-over fashion separated by at least 2 weeks. Participants will be placed in a heated environment for the duration of the exercise intervention.

Conditions
Dehydration
Keywords
dehydration, fluid balance, exercise, heat, body weight, performance
Medical subject headings
Dehydration, Motor Activity, Body Weight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise InterventionOther

    Exercise intervention trials will consist of a steady-state bout of exercise at ~70% VO2peak and a timed performance test on a cycle ergometer in a heated environment.

Study groups in NCT01893853
Study groupRoleWhat they receive
WaterOtherElectrolyte- and mineral-free water with exercise intervention
Receives: Other: Exercise Intervention
PlaceboPlacebo comparatorCalorie- and electrolyte-free, sweetened flavored water with exercise intervention
Receives: Other: Exercise Intervention
Carbohydrate-electrolyte beverageExperimentalCommercially-available flavored beverage carbohydrate-electrolyte beverage with Exercise Intervention
Receives: Other: Exercise Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fluid Balance

    Fluid balance will be determined by change in body weight during the 120 minutes steady-state exercise bout in the heat.

    Measured: 120 minutes

Secondary outcomes (5)

  1. Rate of fluid uptake in the GI tract

    Fluid uptake in the GI tract be assessed by D20 accumulation in the plasma.

    Measured: 30 minutes

  2. Amount of carbohydrate oxidized

    Carbohydrate oxidation rates will be assessed by indirect calorimetry.

    Measured: 120 minutes

  3. Cardiovascular responses

    Heart rate and blood pressure will be assessed during exercise.

    Measured: 120 minutes

  4. Thermoregulatory responses

    Body temperatures will be assessed during exercise.

    Measured: 120 minutes

  5. Physical Performance

    Performance during the timed exercise trial will be improved with carbohydrate-electrolyte beverage intake compared with water and placebo intake.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2013 (estimated)
  2. Study startOct 2012
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

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
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01893853
Sponsor's protocol ID
PBRC 12038
Acronym
APEX
Status last verified
Sep 2022
First submitted
17 Jun 2013
Last updated
15 Sep 2022
Results posted
No
Data monitoring committee
No

Publications

  • Latzka WA, Sawka MN, Montain SJ, Skrinar GS, Fielding RA, Matott RP, Pandolf KB. Hyperhydration: thermoregulatory effects during compensable exercise-heat stress. J Appl Physiol (1985). 1997 Sep;83(3):860-6. doi: 10.1152/jappl.1997.83.3.860.

    PubMed 9292474

  • Latzka WA, Sawka MN, Montain SJ, Skrinar GS, Fielding RA, Matott RP, Pandolf KB. Hyperhydration: tolerance and cardiovascular effects during uncompensable exercise-heat stress. J Appl Physiol (1985). 1998 Jun;84(6):1858-64. doi: 10.1152/jappl.1998.84.6.1858.

    PubMed 9609777

  • Armstrong LE, Costill DL, Fink WJ. Influence of diuretic-induced dehydration on competitive running performance. Med Sci Sports Exerc. 1985 Aug;17(4):456-61. doi: 10.1249/00005768-198508000-00009.

    PubMed 4033401

  • Cheuvront SN, Carter R 3rd, Castellani JW, Sawka MN. Hypohydration impairs endurance exercise performance in temperate but not cold air. J Appl Physiol (1985). 2005 Nov;99(5):1972-6. doi: 10.1152/japplphysiol.00329.2005. Epub 2005 Jul 14.

    PubMed 16024524

  • Greenleaf JE, Sargent F 2nd. Voluntary dehydration in man. J Appl Physiol. 1965 Jul;20(4):719-24. doi: 10.1152/jappl.1965.20.4.719. No abstract available.

    PubMed 5838723

  • Hubbard RW, Sandick BL, Matthew WT, Francesconi RP, Sampson JB, Durkot MJ, Maller O, Engell DB. Voluntary dehydration and alliesthesia for water. J Appl Physiol Respir Environ Exerc Physiol. 1984 Sep;57(3):868-73. doi: 10.1152/jappl.1984.57.3.868.

    PubMed 6490470

  • Hamilton MT, Gonzalez-Alonso J, Montain SJ, Coyle EF. Fluid replacement and glucose infusion during exercise prevent cardiovascular drift. J Appl Physiol (1985). 1991 Sep;71(3):871-7. doi: 10.1152/jappl.1991.71.3.871.

    PubMed 1757323

  • Nose H, Mack GW, Shi XR, Nadel ER. Role of osmolality and plasma volume during rehydration in humans. J Appl Physiol (1985). 1988 Jul;65(1):325-31. doi: 10.1152/jappl.1988.65.1.325.

    PubMed 3403476

  • Nose H, Mack GW, Shi XR, Nadel ER. Involvement of sodium retention hormones during rehydration in humans. J Appl Physiol (1985). 1988 Jul;65(1):332-6. doi: 10.1152/jappl.1988.65.1.332.

    PubMed 3042742

  • Wilk B, Bar-Or O. Effect of drink flavor and NaCL on voluntary drinking and hydration in boys exercising in the heat. J Appl Physiol (1985). 1996 Apr;80(4):1112-7. doi: 10.1152/jappl.1996.80.4.1112.

    PubMed 8926234

  • Rivera-Brown AM, Gutierrez R, Gutierrez JC, Frontera WR, Bar-Or O. Drink composition, voluntary drinking, and fluid balance in exercising, trained, heat-acclimatized boys. J Appl Physiol (1985). 1999 Jan;86(1):78-84. doi: 10.1152/jappl.1999.86.1.78.

    PubMed 9887116

  • Wemple RD, Morocco TS, Mack GW. Influence of sodium replacement on fluid ingestion following exercise-induced dehydration. Int J Sport Nutr. 1997 Jun;7(2):104-16. doi: 10.1123/ijsn.7.2.104.

    PubMed 9189781

  • Szlyk PC, Sils IV, Francesconi RP, Hubbard RW, Armstrong LE. Effects of water temperature and flavoring on voluntary dehydration in men. Physiol Behav. 1989 Mar;45(3):639-47. doi: 10.1016/0031-9384(89)90085-1.

    PubMed 2756057

  • Vrijens DM, Rehrer NJ. Sodium-free fluid ingestion decreases plasma sodium during exercise in the heat. J Appl Physiol (1985). 1999 Jun;86(6):1847-51. doi: 10.1152/jappl.1999.86.6.1847.

    PubMed 10368348

  • American College of Sports Medicine; Sawka MN, Burke LM, Eichner ER, Maughan RJ, Montain SJ, Stachenfeld NS. American College of Sports Medicine position stand. Exercise and fluid replacement. Med Sci Sports Exerc. 2007 Feb;39(2):377-90. doi: 10.1249/mss.0b013e31802ca597.

    PubMed 17277604

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Intervention in people with Dehydration, run by Pennington Biomedical Research Center at 1 site in United States.

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 2 inclusion and 2 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 15 Sep 2022. 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 United States. 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?

Fluid Balance (time frame: 120 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01893853, which also lists 21 linked publications.

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 15 Sep 2022.

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