Clinical Trial to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults

Summary

Dehydration lowers both physical and mental performance if it is severe enough. Performance declines are more pronounced in hot conditions or after prolonged strenuous activity such as exercise. Most individuals drink less than their sweat losses during activity, while some individuals overdrink and develop a sodium deficiency.

Water and electrolyte balance must be restored as part of the recovery process after any activity that causes sweating. Plain water causes a decrease in plasma sodium concentration and osmolality, which reduces the desire to drink and increases urine production. Unless the volume ingested exceeds the loss, individuals are in net negative fluid balance throughout the recovery period due to urinary losses. When sodium and potassium are added to rehydration fluids, urine production is reduced in the hours following rehydration. Rehydration is only possible if a volume of fluid equal to or greater than the amount lost through sweat is consumed, together with adequate electrolytes.

The test products for this study, TP1 and TP2, are novel hydration beverage formulas. They are an electrolyte drink mixture with five essential vitamins and three times more electrolytes than typical sports beverages. The test products create an osmotic force that permits water to be supplied to the bloodstream sooner in the digestive system by using a specific ratio of sodium, glucose, and potassium. This randomized, placebo-controlled, semi-blind, crossover study will evaluate the effects of the test products on rehydration in healthy adults.

Conditions

• Dehydration
• Rehydration
• Exercise Performance
• Exercise Recovery
• Fluid Balance
• Cognitive Performance

Interventions

OTHER

TP1

Participants will receive TP1 during one experimental visit.

OTHER

TP2

Participants will receive TP2 during one experimental visit.

OTHER

Placebo

Participants will receive placebo during one experimental visit.

Sponsors & Collaborators

• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

  collaborator NETWORK

• University of South Carolina

  collaborator OTHER

• Liquid I.V.

  lead OTHER

Principal Investigators

• Sean Arent, PhD · University of South Carolina

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-08-01

Primary Completion

2022-11-01

Completion

2023-01-01

Countries

• United States

Study Locations