- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01893853
Fluid Balance During Exercise in the Heat With Water, Flavored Placebo, or a Carbohydrate-electrolyte Beverage Intake (The APEX Study) (APEX)
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Pennington Biomedical Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males aged 18-35 years
- Healthy (No uncontrolled disease)
Exclusion Criteria:
- No medications that influence fluid balance
- No uncontrolled disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Water
Electrolyte- and mineral-free water with exercise intervention
|
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.
|
|
Placebo Comparator: Placebo
Calorie- and electrolyte-free, sweetened flavored water with exercise intervention
|
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.
|
|
Experimental: Carbohydrate-electrolyte beverage
Commercially-available flavored beverage carbohydrate-electrolyte beverage with Exercise Intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fluid Balance
Time Frame: 120 minutes
|
Fluid balance will be determined by change in body weight during the 120 minutes steady-state exercise bout in the heat.
|
120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of fluid uptake in the GI tract
Time Frame: 30 minutes
|
Fluid uptake in the GI tract be assessed by D20 accumulation in the plasma.
|
30 minutes
|
|
Amount of carbohydrate oxidized
Time Frame: 120 minutes
|
Carbohydrate oxidation rates will be assessed by indirect calorimetry.
|
120 minutes
|
|
Cardiovascular responses
Time Frame: 120 minutes
|
Heart rate and blood pressure will be assessed during exercise.
|
120 minutes
|
|
Thermoregulatory responses
Time Frame: 120 minutes
|
Body temperatures will be assessed during exercise.
|
120 minutes
|
|
Physical Performance
Time Frame: 30 minutes
|
Performance during the timed exercise trial will be improved with carbohydrate-electrolyte beverage intake compared with water and placebo intake.
|
30 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Timothy S Church, MD, MPH, PhD, Pennington Biomedical Research Center
- Study Chair: Neil M Johannsen, PhD, Louisiana State University-Department of Kinesiology
- Study Chair: Ronald B Monce, PA-c, Pennington Biomedical Research Center
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Eur J Appl Physiol 1993;66(6):552.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 12038
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