The Effect of AMP Human Sodium Bicarbonate Lotion on Hydration

Summary

The purpose of this research study is to evaluate the effects of a topical sodium bicarbonate lotion on physiological and psychological responses associated with hydration status and fluid balance in humans during passive heat stress. Currently, the ingestion of sodium has been an effective measure for improvements in fluid regulation and hydration status in humans. However, the investigators do not know its regulatory relationship with measurements of fluid balance when supplemented through the skin.

Conditions

• Fluid Retention
• Fluid Loss
• Sodium Retention
• Cognitive Change
• Heat Exposure
• Hyperhydration
• Electrolyte and Fluid Balance Conditions

Interventions

OTHER

PR Lotion - AMP Human Performance

Sodium Bicarbonate Topical Solution. For use of the PR Lotion solution, consumers are instructed to apply the lotion to areas of the body that have been identified as most likely to use during their activity (i.e. calves and thighs for runners, shoulders and forearms for swimmers, etc.). Moreover, the product can be applied up to 2 hours prior to beginning a workout or event with one use supporting a 4-6 hour workout. AMP Human has also verified the safety of their product as being well tolerated in consumers \>2 years of age unless there is a known allergy to an ingredient on the label. Moreover, to the company's knowledge no side effects have been reported per the SAFETY Section at https://amphuman.com/pages/faq.

OTHER

Placebo Lotion

Placebo Topical Solution. Lotion will be created by the AMP Human Performance company and will include all ingredients similar to the PR Lotion product except for the exclusion of sodium bicarbonate.

Sponsors & Collaborators

• AMP Human; Park City, UT

  collaborator UNKNOWN

• United States Department of Defense

  collaborator FED

• University of Connecticut

  lead OTHER

Principal Investigators

• Douglas J Casa, PhD · Korey Stringer Institute - UConn

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-09

Primary Completion

2021-04-09

Completion

2021-04-09

Countries

• United States

Study Locations