CompletedNot Applicable

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

United States18 participantsStarted 2021-09-03

Plain-language summary

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.

Who can participate

Age range18 Years – 45 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- 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.

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 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).

What they're measuring

Hydration Status - Change in Acute Urine USG

Timeframe: Phase-specific PRE Session

Hydration Status - Change in 24-h Urine USG

Timeframe: Phase-specific PRE Session

Hydration Status - Change in Acute Urine USG

Timeframe: Intervention Trial at the -45 minute mark

Hydration Status - Change in 24-h Urine USG

Timeframe: Intervention Trial at the -45 minute mark

Hydration Status - Change in Urine USG

Timeframe: Intervention Trial at the 0 minute mark

Hydration Status - Change in Urine USG

Timeframe: Intervention Trial at the 40 minute mark

Hydration Status - Change in Acute Urine USG

Timeframe: Intervention Trial at the 80 minute mark

Hydration Status - Change in Urine USG

Timeframe: Intervention Trial at the 220 minute mark

Trial details

NCT IDNCT05092854

SponsorUniversity of Connecticut

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-01

View on ClinicalTrials.gov More Fluid Retention trials

Plain-language summary

Who can participate

Age range18 Years – 45 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- 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.

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 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).

What they're measuring

Hydration Status - Change in Acute Urine USG

Timeframe: Phase-specific PRE Session

Hydration Status - Change in 24-h Urine USG

Timeframe: Phase-specific PRE Session

Hydration Status - Change in Acute Urine USG

Timeframe: Intervention Trial at the -45 minute mark

Hydration Status - Change in 24-h Urine USG

Timeframe: Intervention Trial at the -45 minute mark

Hydration Status - Change in Urine USG

Timeframe: Intervention Trial at the 0 minute mark

Hydration Status - Change in Urine USG

Timeframe: Intervention Trial at the 40 minute mark

Hydration Status - Change in Acute Urine USG

Timeframe: Intervention Trial at the 80 minute mark

Hydration Status - Change in Urine USG

Timeframe: Intervention Trial at the 220 minute mark