NCT01893853

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 9, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

September 15, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

June 17, 2013

Last Update Submit

September 13, 2022

Conditions

Dehydration

Keywords

dehydrationfluid balanceexerciseheatbody weightperformance

Outcome Measures

Primary Outcomes (1)

  • Fluid Balance

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

    120 minutes

Secondary Outcomes (5)

  • Rate of fluid uptake in the GI tract

    30 minutes

  • Amount of carbohydrate oxidized

    120 minutes

  • Cardiovascular responses

    120 minutes

  • Thermoregulatory responses

    120 minutes

  • Physical Performance

    30 minutes

Study Arms (3)

Water

OTHER

Electrolyte- and mineral-free water with exercise intervention

Other: Exercise Intervention

Placebo

PLACEBO COMPARATOR

Calorie- and electrolyte-free, sweetened flavored water with exercise intervention

Other: Exercise Intervention

Carbohydrate-electrolyte beverage

EXPERIMENTAL

Commercially-available flavored beverage carbohydrate-electrolyte beverage with Exercise Intervention

Other: Exercise Intervention

Interventions

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.

Carbohydrate-electrolyte beveragePlaceboWater

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • No medications that influence fluid balance
  • No uncontrolled disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (21)

  • 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.

    PMID: 9292474BACKGROUND

  • 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.

    PMID: 9609777BACKGROUND

  • 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.

    PMID: 4033401BACKGROUND

  • 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.

    PMID: 16024524BACKGROUND

  • 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.

    PMID: 5838723BACKGROUND

  • 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.

    PMID: 6490470BACKGROUND

  • 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.

    PMID: 1757323BACKGROUND

  • 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.

    PMID: 3403476BACKGROUND

  • 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.

    PMID: 3042742BACKGROUND

  • 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.

    PMID: 8926234BACKGROUND

  • 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.

    PMID: 9887116BACKGROUND

  • 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.

    PMID: 9189781BACKGROUND

  • 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.

    PMID: 2756057BACKGROUND

  • 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.

    PMID: 10368348BACKGROUND

  • 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.

    PMID: 17277604BACKGROUND

  • Mitchell JW, Nadel ER, Stolwijk JA. Respiratory weight losses during exercise. J Appl Physiol. 1972 Apr;32(4):474-6. doi: 10.1152/jappl.1972.32.4.474. No abstract available.

    PMID: 5026494BACKGROUND

  • Brisson GR, Boisvert P, Peronnet F, Perrault H, Boisvert D, Lafond JS. A simple and disposable sweat collector. Eur J Appl Physiol Occup Physiol. 1991;63(3-4):269-72. doi: 10.1007/BF00233860.

    PMID: 1761019BACKGROUND

  • Buono MJ, Jechort A, Marques R, Smith C, Welch J. Comparison of infrared versus contact thermometry for measuring skin temperature during exercise in the heat. Physiol Meas. 2007 Aug;28(8):855-9. doi: 10.1088/0967-3334/28/8/008. Epub 2007 Jul 6.

    PMID: 17664677BACKGROUND

  • Armstrong LE, Maresh CM, Gabaree CV, Hoffman JR, Kavouras SA, Kenefick RW, Castellani JW, Ahlquist LE. Thermal and circulatory responses during exercise: effects of hypohydration, dehydration, and water intake. J Appl Physiol (1985). 1997 Jun;82(6):2028-35. doi: 10.1152/jappl.1997.82.6.2028.

    PMID: 9173973BACKGROUND

  • Temesi J, Johnson NA, Raymond J, Burdon CA, O'Connor HT. Carbohydrate ingestion during endurance exercise improves performance in adults. J Nutr. 2011 May;141(5):890-7. doi: 10.3945/jn.110.137075. Epub 2011 Mar 16.

    PMID: 21411610BACKGROUND

  • Davis JM, Lamb DR, Burgess WA, Bartoli WP. Accumulation of deuterium oxide in body fluids after ingestion of D2O-labeled beverages. J Appl Physiol (1985). 1987 Nov;63(5):2060-6. doi: 10.1152/jappl.1987.63.5.2060.

    PMID: 3693238BACKGROUND

MeSH Terms

Conditions

DehydrationMotor ActivityBody Weight

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorSigns and Symptoms

Study Officials

  • Timothy S Church, MD, MPH, PhD

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

  • Neil M Johannsen, PhD

    Louisiana State University-Department of Kinesiology

    STUDY CHAIR

  • Ronald B Monce, PA-c

    Pennington Biomedical Research Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2013

First Posted

July 9, 2013

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

September 15, 2022

Record last verified: 2022-09

Locations

US(1)