The Effect of AMP Human Sodium Bicarbonate Lotion on Hydration

NCT04598386 | Completed

• 1 other identifier: H20-0100
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sodium Bicarbonate; Topical Lotion

Outcome Measures

Primary Outcomes (69)

• Fluid Retention - Change in Expelled Urine Volume

  Assessment of fluid retention via collection of urine volume

  Hydration Baseline Day 1

• Fluid Retention - Change in Expelled Urine Volume

  Assessment of fluid retention via collection of urine volume

  Hydration Baseline Day 2

• Fluid Retention - Change in Expelled Urine Volume

  Assessment of fluid retention via collection of urine volume

  Hydration Baseline Day 3

• Fluid Retention - Change in Expelled Urine Volume

  Assessment of fluid retention via collection of urine volume

  Intervention Trial (Day 4) at the -90 minute mark.

• Fluid Retention - Change in Expelled Urine Volume

  Assessment of fluid retention via collection of urine volume

  Intervention Trial (Day 4) at the 0 minute mark.

• Fluid Retention - Change in Expelled Urine Volume

  Assessment of fluid retention via collection of urine volume

  Intervention Trial (Day 4) at the 30 minute mark.

• Fluid Retention - Change in Expelled Urine Volume

  Assessment of fluid retention via collection of urine volume

  Intervention Trial (Day 4) at the 60 minute mark.

• Fluid Retention - Change in Expelled Urine Volume

  Assessment of fluid retention via collection of urine volume

  Intervention Trial (Day 4) at the 90 minute mark.

• Fluid Retention - Change in Expelled Urine Volume

  Assessment of fluid retention via collection of urine volume

  Intervention Trial (Day 4) at the 120 minute mark.

• Fluid Retention - Change in Expelled Urine Volume

  Assessment of fluid retention via collection of urine volume

  Intervention Trial (Day 4) at the 180 minute mark.

• Kidney Function - Change in Aldosterone Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Hydration Baseline Day 1

• Kidney Function - Change in Aldosterone Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Hydration Baseline Day 2

• Kidney Function - Change in Aldosterone Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Hydration Baseline Day 3

• Kidney Function - Change in Aldosterone Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the -90 minute mark.

• Kidney Function - Change in Aldosterone Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the -30 minute mark.

• Kidney Function - Change in Aldosterone Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 0 minute mark.

• Kidney Function - Change in Aldosterone Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 60 minute mark.

• Kidney Function - Change in Aldosterone Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 120 minute mark.

• Kidney Function - Change in Aldosterone Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 180 minute mark.

• Kidney Function - Change in Copeptin Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Hydration Baseline Day 1

• Kidney Function - Change in Copeptin Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Hydration Baseline Day 2

• Kidney Function - Change in Copeptin Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Hydration Baseline Day 3

• Kidney Function - Change in Copeptin Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the -90 minute mark.

• Kidney Function - Change in Copeptin Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the -30 minute mark.

• Kidney Function - Change in Copeptin Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 0 minute mark.

• Kidney Function - Change in Copeptin Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 60 minute mark.

• Kidney Function - Change in Copeptin Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 120 minute mark.

• Kidney Function - Change in Copeptin Response

  Assessment of kidney function in regards to fluid retention via assessment of blood biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 180 minute mark.

• Kidney Function - Change in Creatinine Response

  Assessment of kidney function in regards to fluid retention via assessment of urine biomarkers associated with kidney function

  Hydration Baseline Day 1

• Kidney Function - Change in Creatinine Response

  Assessment of kidney function in regards to fluid retention via assessment of urine biomarkers associated with kidney function

  Hydration Baseline Day 2

• Kidney Function - Change in Creatinine Response

  Assessment of kidney function in regards to fluid retention via assessment of urine biomarkers associated with kidney function

  Hydration Baseline Day 3

• Kidney Function - Change in Creatinine Response

  Assessment of kidney function in regards to fluid retention via assessment of urine biomarkers associated with kidney function

  Intervention Trial (Day 4) at the -90 minute mark.

• Kidney Function - Change in Creatinine Response

  Assessment of kidney function in regards to fluid retention via assessment of urine biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 0 minute mark.

• Kidney Function - Change in Creatinine Response

  Assessment of kidney function in regards to fluid retention via assessment of urine biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 60 minute mark.

• Kidney Function - Change in Creatinine Response

  Assessment of kidney function in regards to fluid retention via assessment of urine biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 120 minute mark.

• Kidney Function - Change in Creatinine Response

  Assessment of kidney function in regards to fluid retention via assessment of urine biomarkers associated with kidney function

  Intervention Trial (Day 4) at the 180 minute mark.

• Change in Whole Blood Sodium Levels

  Assessment of fluid retention via whole blood sodium (electrolyte levels) through blood biomarkers

  Hydration Baseline Day 1

• Change in Whole Blood Sodium Levels

  Assessment of fluid retention via whole blood sodium (electrolyte levels) through blood biomarkers

  Hydration Baseline Day 2

• Change in Whole Blood Sodium Levels

  Assessment of fluid retention via whole blood sodium (electrolyte levels) through blood biomarkers

  Hydration Baseline Day 3

• Change in Whole Blood Sodium Levels

  Assessment of fluid retention via whole blood sodium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -90 minute mark.

• Change in Whole Blood Sodium Levels

  Assessment of fluid retention via whole blood sodium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -75 minute mark.

• Change in Whole Blood Sodium Levels

  Assessment of fluid retention via whole blood sodium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -60 minute mark.

• Change in Whole Blood Sodium Levels

  Assessment of fluid retention via whole blood sodium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -30 minute mark.

• Change in Whole Blood Sodium Levels

  Assessment of fluid retention via whole blood sodium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 0 minute mark.

• Change in Whole Blood Sodium Levels

  Assessment of fluid retention via whole blood sodium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 60 minute mark.

• Change in Whole Blood Sodium Levels

  Assessment of fluid retention via whole blood sodium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 120 minute mark.

• Change in Whole Blood Sodium Levels

  Assessment of fluid retention via whole blood sodium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 180 minute mark.

• Change in Whole Blood Potassium Levels

  Assessment of fluid retention via whole blood potassium (electrolyte levels) through blood biomarkers

  Hydration Baseline Day 1

• Change in Whole Blood Potassium Levels

  Assessment of fluid retention via whole blood potassium (electrolyte levels) through blood biomarkers

  Hydration Baseline Day 2

• Change in Whole Blood Potassium Levels

  Assessment of fluid retention via whole blood potassium (electrolyte levels) through blood biomarkers

  Hydration Baseline Day 3

• Change in Whole Blood Potassium Levels

  Assessment of fluid retention via whole blood potassium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -90 minute mark.

• Change in Whole Blood Potassium Levels

  Assessment of fluid retention via whole blood potassium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -75 minute mark.

• Change in Whole Blood Potassium Levels

  Assessment of fluid retention via whole blood potassium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -60 minute mark.

• Change in Whole Blood Potassium Levels

  Assessment of fluid retention via whole blood potassium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -30 minute mark.

• Change in Whole Blood Potassium Levels

  Assessment of fluid retention via whole blood potassium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 0 minute mark.

• Change in Whole Blood Potassium Levels

  Assessment of fluid retention via whole blood potassium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 60 minute mark.

• Change in Whole Blood Potassium Levels

  Assessment of fluid retention via whole blood potassium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 120 minute mark.

• Change in Whole Blood Potassium Levels

  Assessment of fluid retention via whole blood potassium (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 180 minute mark.

• Change in Whole Blood Chloride Levels

  Assessment of fluid retention via whole blood chloride (electrolyte levels) through blood biomarkers

  Hydration Baseline Day 1

• Change in Whole Blood Chloride Levels

  Assessment of fluid retention via whole blood chloride (electrolyte levels) through blood biomarkers

  Hydration Baseline Day 2

• Change in Whole Blood Chloride Levels

  Assessment of fluid retention via whole blood chloride (electrolyte levels) through blood biomarkers

  Hydration Baseline Day 3

• Change in Whole Blood Chloride Levels

  Assessment of fluid retention via whole blood chloride (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -90 minute mark.

• Change in Whole Blood Chloride Levels

  Assessment of fluid retention via whole blood chloride (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -75 minute mark.

• Change in Whole Blood Chloride Levels

  Assessment of fluid retention via whole blood chloride (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -60 minute mark.

• Change in Whole Blood Chloride Levels

  Assessment of fluid retention via whole blood chloride (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the -30 minute mark.

• Change in Whole Blood Chloride Levels

  Assessment of fluid retention via whole blood chloride (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 0 minute mark.

• Change in Whole Blood Chloride Levels

  Assessment of fluid retention via whole blood chloride (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 60 minute mark.

• Change in Whole Blood Chloride Levels

  Assessment of fluid retention via whole blood chloride (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 120 minute mark.

• Change in Whole Blood Chloride Levels

  Assessment of fluid retention via whole blood chloride (electrolyte levels) through blood biomarkers

  Intervention Trial (Day 4) at the 180 minute mark.

Secondary Outcomes (127)

• Fluid Retention - Change in Whole Blood Hematocrit Levels

  Hydration Baseline 1

• Fluid Retention - Change in Whole Blood Hematocrit Levels

  Hydration Baseline 2

• Fluid Retention - Change in Whole Blood Hematocrit Levels

  Hydration Baseline 3

• Fluid Retention - Change in Whole Blood Hematocrit Levels

  Intervention Trial (Day 4) at the -90 minute mark.

• Fluid Retention - Change in Whole Blood Hematocrit Levels

  Intervention Trial (Day 4) at the -75 minute mark.

Study Arms (2)

PR Lotion Topical Solution

EXPERIMENTAL

Approximately 50 grams of PR Lotion will be applied by the participants to their upper extremities (arms) in addition to their neck, upper back, chest, and midsection if necessary. This lotion will be applied once during the 4th of session of their PR Lotion Phase and will remain on the skin for approximately 4.5 hours.

Other: PR Lotion - AMP Human Performance

Placebo Lotion Topical Solution

PLACEBO COMPARATOR

Approximately 50 grams of the Placebo Lotion will be applied by the participants to their upper extremities (arms) in addition to their neck, upper back, chest, and midsection if necessary. The only difference in ingredients for this Placebo Lotion will be the exclusion of the sodium bicarbonate ingredient. This lotion will be applied once during the 4th of session of their Placebo Lotion Phase and will remain on the skin for approximately 4.5 hours.

Other: Placebo Lotion

Interventions

PR Lotion - AMP Human Performance OTHER

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.

Also known as: NDC Code: 72358-101-01, NDC Code: 72358-101-02, NDC Code: 72358-101-03

PR Lotion Topical Solution

Placebo Lotion OTHER

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.

Placebo Lotion Topical Solution

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of Connecticut: lead
• AMP Human; Park City, UT: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Korey Stringer Institute at the University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Hypernatremia; Water Intoxication

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Douglas J Casa, PhD

  Korey Stringer Institute - UConn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 22, 2020
• Study Start: December 9, 2020
• Primary Completion: April 9, 2021
• Study Completion: April 9, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)