CompletedNot Applicable

The Effect of AMP Human Sodium Bicarbonate Lotion on Hydration

United States20 participantsStarted 2020-12-09

Plain-language 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.

Who can participate

Age range18 Years – 35 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Fluid Retention - Change in Expelled Urine Volume

Timeframe: Hydration Baseline Day 1

Fluid Retention - Change in Expelled Urine Volume

Timeframe: Hydration Baseline Day 2

Fluid Retention - Change in Expelled Urine Volume

Timeframe: Hydration Baseline Day 3

Fluid Retention - Change in Expelled Urine Volume

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

Fluid Retention - Change in Expelled Urine Volume

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

Fluid Retention - Change in Expelled Urine Volume

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

Fluid Retention - Change in Expelled Urine Volume

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

Fluid Retention - Change in Expelled Urine Volume

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

Trial details

NCT IDNCT04598386

SponsorUniversity of Connecticut

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-09

View on ClinicalTrials.gov More Fluid Retention trials

Plain-language summary

Who can participate

Age range18 Years – 35 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Fluid Retention - Change in Expelled Urine Volume

Timeframe: Hydration Baseline Day 1

Fluid Retention - Change in Expelled Urine Volume

Timeframe: Hydration Baseline Day 2

Fluid Retention - Change in Expelled Urine Volume

Timeframe: Hydration Baseline Day 3

Fluid Retention - Change in Expelled Urine Volume

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

Fluid Retention - Change in Expelled Urine Volume

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

Fluid Retention - Change in Expelled Urine Volume

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

Fluid Retention - Change in Expelled Urine Volume

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

Fluid Retention - Change in Expelled Urine Volume

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