The Effect of AMP Human Sodium Bicarbonate Lotion on Dehydrated Heat Stress

Summary

The primary purpose of the proposed study is to evaluate the effects of a topical sodium bicarbonate lotion (PR Lotion, AMP Human, Park City, UT) on measures of hydration status and fluid balance in humans when exposed to the heat while resting and during light/moderate aerobic exercise. A secondary purpose is to examine these same effects with two differing dosage patterns of the lotion. A tertiary purpose is to investigate the effect of an amino acid rehydration beverage in comparison to a placebo on measurements of hydration, subjective assessments of stress, and vestibular as well as musculoskeletal measures of fatigue for up to 24-hours after the completion of both passive and exertional heat stress within a dehydrated state.

Conditions

• Fluid Retention
• Sodium Retention
• Heat Stress
• Dehydration (Physiology)
• Renal Injury
• 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 Names: NDC Code: 72358-101-01 NDC Code: 72358-101-02 NDC Code: 72358-101-03

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.

OTHER

AminoVital - Rapid Recovery

AminoVITAL Rapid Recovery is a commercially available supplement that is not currently regulated by the FDA but does complete both internal quality control and third-party testing for all of their products. AminoVITAL Rapid Recovery has been certified by the Banned Substance Control Group (BSCG; https://www.bscg.org/certified-drug- free-supplements/?AminoVITAL) and has been certified to be free of 496+ drugs including WADA Prohibited Substances as well as prescription, over the counter, and illicit drugs not banned in sport. AminoVITAL Rapid Recovery is safe to consume multiple times within a single day and has been found most effective when taken within 30 minutes of cessation of exercise. No known side effects are associated with the ingestion of aminoVITAL Rapid Recovery; however, side effects of amino acid toxicity include gastrointestinal distress, nausea and headache.

OTHER

Placebo Supplement

Supplement will be created by the aminoVITAL company and will include all ingredients similar to the commercially available Rapid Recovery product except for the exclusion of the amino acid blend.

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

45 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-09-03

Primary Completion

2022-08-01

Completion

2022-08-01

Countries

• United States

Study Locations