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

Completed · Not applicable · Has a placebo group

Conditions studied: Fluid Retention, Sodium Retention, Heat Stress, Dehydration (Physiology), Renal Injury, Electrolyte and Fluid Balance Conditions

In brief

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.

Key facts

Study ID

NCT05092854

Run by

University of Connecticut

People needed

18

Starts

2021-09-03

Expected to finish

2022-08-01

Last updated by the study team

2022-10-24

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Males within the age range of 18- 45 years old.
• Individuals who are classified as recreationally active adults as indicated by a VO2max minimum (45 ml/kg/min)
• Individuals who measure with a BMI of ≤ 28
• Individuals who have been medically cleared for participation in this study by the medical safety monitor.

You may not qualify if…

• Cannot understand English (written and/or verbally communicated).
• Hearing impaired to where verbal communications cannot be understood and/or followed safely.
• Individuals who report a history of COVID-19 unless cleared by a physician for exercise at the performance level required to participate in this study. The physician must be made aware of what is required to participate in this study.
• Individuals who self-report history of complications with psychological disorders or chronic illness (eating disorders, cardiovascular, kidney, liver, metabolic, neuromuscular, pulmonary, integumentary, and/or sickle cell disease).
• Individuals who have chronic health problems that may affect the participant's ability to thermoregulate or sweat normally.
• Individuals who have a history of exertional heat illness within the past 3 years.
• Individuals who are taking any prescription or non-prescription medication(s) that may specifically impact cardiometabolic, pulmonary, renal, integumentary, and/or thermoregulatory function (i.e. amphetamines, antihypertensives, anticholinergics, acetaminophen, NSAIDs, aspirin, and water pills).
• Individuals who are taking any prescription medication for diabetes mellitus, Parkinson's disease, or kidney disease.
• Individuals who have donated blood within the previous month.
• Individuals who have an implanted pacemaker or internal defibrillator.
• Individuals who report a history of claustrophobia
• Individuals classified as hypertensive while at rest (SBP: ≥140 mmHg and/or DBP: ≥90 mmHg; will be measured during first visit).
• Individuals who have not abstained from use of supplements that may affect/enhance hydration status and/or rehydration protocol measurements (i.e. creatine, sodium bicarbonate, potassium, magnesium, dandelion, vitamin B, protein powder, BCAAs, fish oil, multivitamins, soluble fiber, other natural diuretics) at time of testing.
• Individuals who are suffering from a current musculoskeletal injury or active lesion of the skin that inhibits the participant's ability to complete all tasks required for participation.
• Individuals who are allergic/sensitive to adhesive materials (i.e., medical tape)
• Individuals who are allergic/sensitive to ingredients within the study-specific Topical Lotions: (Menthol [0.5%], sodium bicarbonate (baking soda), water, isopropyl palmitate, lecithin, poloxamer 407, cetyl alcohol, propylene glycol, denatured alcohol, benzyl alcohol, polyglyceryl-4 laurate, sodium hydroxide, sodium lauryl sulfate, sorbic acid, and fragrance) as well as iodine and/or medical tape.
• Individuals who are allergic/sensitive to ingredients within the study specific amino acid beverages: highly branched cyclic dextrin, citric acid, malic acid, natural fruit flavor, rebaudioside (stevia leaf extract), and vegetable juice for color.

Where it is running

• Korey Stringer Institute at the University of Connecticut — Storrs, Connecticut, United States

Full record on ClinicalTrials.gov

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