The Effect of AMP Human Sodium Bicarbonate Lotion on Hydration

Completed · Not applicable · Has a placebo group

Conditions studied: Fluid Retention, Fluid Loss, Sodium Retention, Cognitive Change, Heat Exposure, Hyperhydration, Electrolyte and Fluid Balance Conditions

In brief

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.

Key facts

Study ID

NCT04598386

Run by

University of Connecticut

People needed

20

Starts

2020-12-09

Expected to finish

2021-04-09

Last updated by the study team

2021-10-14

Who can join

Age: 18 and older, up to 35. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Males within the age range of 18-35 years old.
• Individuals who are classified as recreationally active individuals: physical activity performed ≥3 days per week with sessions lasting ≥30 minutes in duration.
• 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 self-report history of complications with psychological disorders or chronic illness (eating disorders, cardiovascular, kidney, liver, metabolic, neuromuscular, pulmonary, 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, and/or thermoregulatory function (i.e. amphetamines, antihypertensives, anticholinergics, acetaminophen, NSAIDs, aspirin, and water pills).
• Individuals who have consumed more than (>3,500 mg) or less than (<2,300 mg) the average amount of sodium consumed per day at time of testing.
• Individuals who have consumed more than (>1.8L) or less than (<0.8L) the average amount of fluids consumed per day at time of testing.
• 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 (i.e. creatine, sodium bicarbonate, potassium, magnesium, dandelion, vitamin B6, other natural diuretics) at time of testing.
• Individuals who report they are suffering from a fever or current illness at time of testing.
• Individuals who are suffering from a current musculoskeletal injury that limits the participant's ability to walk, stand, and/or sit upright in a chair for long periods of time.
• Individuals who have an active lesion at the location of topical solution application.
• Individuals how 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).
• Individuals who are allergic/sensitive to iodine, water-based ultrasound solution, and/or medical tape.
• Individuals who have experienced any recent major life events (i.e. death in family, divorce, wedding) in the previous 6 months.
• Individuals who have donated blood within the previous month.
• Individuals who have an implanted pacemaker or internal defibrillator.
• Individuals who use tobacco products (including smoking cessation products).

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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