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 range

18 Years – 35 Years

Sex

MALE

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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.

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 range

18 Years – 35 Years

Sex

MALE

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).

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.