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

Dehydration Clinical Trial

— APEX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893853
• Other study ID #: PBRC 12038
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2022
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Males aged 18-35 years

• Healthy (No uncontrolled disease)

Exclusion Criteria:

• No medications that influence fluid balance

• No uncontrolled disease

Related Conditions & MeSH terms

• Dehydration

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

References & Publications (21)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Brisson GR, Boisvert P, Péronnet 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. Erratum in: Eur J Appl Physiol 1993;66(6):552. — View Citation

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. Epub 2007 Jul 6. — View Citation

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. Epub 2005 Jul 14. — View Citation

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. — View Citation

Greenleaf JE, Sargent F 2nd. Voluntary dehydration in man. J Appl Physiol. 1965 Jul;20(4):719-24. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Mitchell JW, Nadel ER, Stolwijk JA. Respiratory weight losses during exercise. J Appl Physiol. 1972 Apr;32(4):474-6. — View Citation

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. — View Citation

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. — View Citation

Rivera-Brown AM, Gutiérrez R, Gutiérrez 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of fluid uptake in the GI tract	Fluid uptake in the GI tract be assessed by D20 accumulation in the plasma.	30 minutes
Secondary	Amount of carbohydrate oxidized	Carbohydrate oxidation rates will be assessed by indirect calorimetry.	120 minutes
Secondary	Cardiovascular responses	Heart rate and blood pressure will be assessed during exercise.	120 minutes
Secondary	Thermoregulatory responses	Body temperatures will be assessed during exercise.	120 minutes
Secondary	Physical Performance	Performance during the timed exercise trial will be improved with carbohydrate-electrolyte beverage intake compared with water and placebo intake.	30 minutes