NCT05092854

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 3, 2021

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 26, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

11 months

First QC Date

September 26, 2021

Last Update Submit

October 21, 2022

Conditions

Fluid RetentionSodium RetentionHeat StressDehydration (Physiology)Renal InjuryElectrolyte and Fluid Balance Conditions

Keywords

Sodium BicarbonateAmino Acid SupplementationTopical LotionRenal Injury

Outcome Measures

Primary Outcomes (177)

  • Hydration Status - Change in Acute Urine USG

    Assessment of hydration status via collection of urine USG

    Phase-specific PRE Session

  • Hydration Status - Change in 24-h Urine USG

    Assessment of hydration status via collection of urine USG

    Phase-specific PRE Session

  • Hydration Status - Change in Acute Urine USG

    Assessment of hydration status via collection of urine USG

    Intervention Trial at the -45 minute mark

  • Hydration Status - Change in 24-h Urine USG

    Assessment of hydration status via collection of urine USG

    Intervention Trial at the -45 minute mark

  • Hydration Status - Change in Urine USG

    Assessment of hydration status via collection of urine USG

    Intervention Trial at the 0 minute mark

  • Hydration Status - Change in Urine USG

    Assessment of hydration status via collection of urine USG

    Intervention Trial at the 40 minute mark

  • Hydration Status - Change in Acute Urine USG

    Assessment of hydration status via collection of urine USG

    Intervention Trial at the 80 minute mark

  • Hydration Status - Change in Urine USG

    Assessment of hydration status via collection of urine USG

    Intervention Trial at the 220 minute mark

  • Hydration Status - Change in Urine USG

    Assessment of hydration status via collection of urine USG

    Rehydration Protocol - 3 hours post-intervention

  • Hydration Status - Change in Urine USG

    Assessment of hydration status via collection of urine USG

    Rehydration Protocol - 6 hours post-intervention

  • Hydration Status - Change in Urine USG

    Assessment of hydration status via collection of urine USG

    Rehydration Protocol -15 hours post-intervention

  • Hydration Status - Change in Urine USG

    Assessment of hydration status via collection of urine USG

    Rehydration Protocol - 24 hours post-intervention

  • Hydration Status - Change in Acute Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Phase-specific PRE Session

  • Hydration Status - Change in 24-h Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Phase-specific PRE Session

  • Hydration Status - Change in Acute Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Intervention Trial at the -45 minute mark

  • Hydration Status - Change in 24-h Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Intervention Trial at the -45 minute mark

  • Hydration Status - Change in Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Intervention Trial at the 0 minute mark

  • Hydration Status - Change in Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Intervention Trial at the 40 minute mark

  • Hydration Status - Change in Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Intervention Trial at the 80 minute mark

  • Hydration Status - Change in Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Intervention Trial at the 220 minute mark

  • Hydration Status - Change in Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Rehydration Protocol - 3 hours post-intervention

  • Hydration Status - Change in Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Rehydration Protocol - 6 hours post-intervention

  • Hydration Status - Change in Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Rehydration Protocol - 15 hours post-intervention

  • Hydration Status - Change in Urine Osmolality

    Assessment of hydration status via collection of urine osmolality

    Rehydration Protocol - 24 hours post-intervention

  • Renal Electrolyte Levels - Change in Acute Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Phase-specific PRE Session

  • Renal Electrolyte Levels - Change in 24-h Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Phase-specific PRE Session

  • Renal Electrolyte Levels - Change in Acute Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Intervention Trial at the -45 minute mark

  • Renal Electrolyte Levels - Change in 24-h Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Intervention Trial at the -45 minute mark

  • Renal Electrolyte Levels - Change in Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Intervention Trial at the 0 minute mark

  • Renal Electrolyte Levels - Change in Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Intervention Trial at the 40 minute mark

  • Renal Electrolyte Levels - Change in Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Intervention Trial at the 80 minute mark

  • Renal Electrolyte Levels - Change in Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Intervention Trial at the 220 minute mark

  • Renal Electrolyte Levels - Change in Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Rehydration Protocol - 3 hours post-intervention

  • Renal Electrolyte Levels - Change in Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Rehydration Protocol - 6 hours post-intervention

  • Renal Electrolyte Levels - Change in Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Rehydration Protocol - 15 hours post-intervention

  • Renal Electrolyte Levels - Change in Urine Sodium

    Assessment of renal electrolyte levels via collection of urine sodium excretion

    Rehydration Protocol - 24 hours post-intervention

  • Renal Electrolyte Levels - Change in Acute Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Phase-specific PRE Session

  • Renal Electrolyte Levels - Change in 24-h Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Phase-specific PRE Session

  • Renal Electrolyte Levels - Change in Acute Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Intervention Trial at the -45 minute mark

  • Renal Electrolyte Levels - Change in 24-h Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Intervention Trial at the -45 minute mark

  • Renal Electrolyte Levels - Change in Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Intervention Trial at the 0 minute mark

  • Renal Electrolyte Levels - Change in Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Intervention Trial at the 40 minute mark

  • Renal Electrolyte Levels - Change in Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Intervention Trial at the 80 minute mark

  • Renal Electrolyte Levels - Change in Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Intervention Trial at the 220 minute mark

  • Renal Electrolyte Levels - Change in Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Rehydration Protocol - 3 hours post-intervention

  • Renal Electrolyte Levels - Change in Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Rehydration Protocol - 6 hours post-intervention

  • Renal Electrolyte Levels - Change in Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Rehydration Protocol - 15 hours post-intervention

  • Renal Electrolyte Levels - Change in Urine Potassium

    Assessment of renal electrolyte levels via collection of urine potassium excretion

    Rehydration Protocol - 24 hours post-intervention

  • Renal Electrolyte Levels - Change in Acute Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Phase-specific PRE Session

  • Renal Electrolyte Levels - Change in 24-h Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Phase-specific PRE Session

  • Renal Electrolyte Levels - Change in Acute Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Intervention Trial at the -45 minute mark

  • Renal Electrolyte Levels - Change in 24-h Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Intervention Trial at the -45 minute mark

  • Renal Electrolyte Levels - Change in Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Intervention Trial at the 0 minute mark

  • Renal Electrolyte Levels - Change in Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Intervention Trial at the 40 minute mark

  • Renal Electrolyte Levels - Change in Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Intervention Trial at the 80 minute mark

  • Renal Electrolyte Levels - Change in Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Intervention Trial at the 220 minute mark

  • Renal Electrolyte Levels - Change in Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Rehydration Protocol - 3 hours post-intervention

  • Renal Electrolyte Levels - Change in Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Rehydration Protocol - 6 hours post-intervention

  • Renal Electrolyte Levels - Change in Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Rehydration Protocol - 15 hours post-intervention

  • Renal Electrolyte Levels - Change in Urine Chloride

    Assessment of renal electrolyte levels via collection of urine chloride excretion

    Rehydration Protocol - 24 hours post-intervention

  • Systemic Electrolyte Levels - Change in Plasma Sodium

    Assessment of circulatory electrolyte levels via collection of plasma sodium levels

    Phase-specific PRE Session

  • Systemic Electrolyte Levels - Change in Plasma Sodium

    Assessment of circulatory electrolyte levels via collection of plasma sodium levels

    Intervention Trial at the -35 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Sodium

    Assessment of circulatory electrolyte levels via collection of plasma sodium levels

    Intervention Trial at the 0 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Sodium

    Assessment of circulatory electrolyte levels via collection of plasma sodium levels

    Intervention Trial at the 20 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Sodium

    Assessment of circulatory electrolyte levels via collection of plasma sodium levels

    Intervention Trial at the 40 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Sodium

    Assessment of circulatory electrolyte levels via collection of plasma sodium levels

    Intervention Trial at the 60 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Sodium

    Assessment of circulatory electrolyte levels via collection of plasma sodium levels

    Intervention Trial at the 80 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Sodium

    Assessment of circulatory electrolyte levels via collection of plasma sodium levels

    Intervention Trial at the 130 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Sodium

    Assessment of circulatory electrolyte levels via collection of plasma sodium levels

    Intervention Trial at the 190 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Sodium

    Assessment of circulatory electrolyte levels via collection of plasma sodium levels

    Intervention Trial at the 220 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Sodium

    Assessment of circulatory electrolyte levels via collection of plasma sodium levels

    Rehydration Protocol - 24 hours post-intervention

  • Systemic Electrolyte Levels - Change in Plasma Potassium

    Assessment of circulatory electrolyte levels via collection of plasma potassium levels

    Phase-specific PRE Session

  • Systemic Electrolyte Levels - Change in Plasma Potassium

    Assessment of circulatory electrolyte levels via collection of plasma potassium levels

    Intervention Trial at the -35 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Potassium

    Assessment of circulatory electrolyte levels via collection of plasma potassium levels

    Intervention Trial at the 0 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Potassium

    Assessment of circulatory electrolyte levels via collection of plasma potassium levels

    Intervention Trial at the 20 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Potassium

    Assessment of circulatory electrolyte levels via collection of plasma potassium levels

    Intervention Trial at the 40 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Potassium

    Assessment of circulatory electrolyte levels via collection of plasma potassium levels

    Intervention Trial at the 60 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Potassium

    Assessment of circulatory electrolyte levels via collection of plasma potassium levels

    Intervention Trial at the 80 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Potassium

    Assessment of circulatory electrolyte levels via collection of plasma potassium levels

    Intervention Trial at the 220 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Potassium

    Assessment of circulatory electrolyte levels via collection of plasma potassium levels

    Rehydration Protocol - 24 hours post-intervention

  • Systemic Electrolyte Levels - Change in Plasma Chloride

    Assessment of circulatory electrolyte levels via collection of plasma chloride levels

    Phase-specific PRE Session

  • Systemic Electrolyte Levels - Change in Plasma Chloride

    Assessment of circulatory electrolyte levels via collection of plasma chloride levels

    Intervention Trial at the -35 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Chloride

    Assessment of circulatory electrolyte levels via collection of plasma chloride levels

    Intervention Trial at the 0 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Chloride

    Assessment of circulatory electrolyte levels via collection of plasma chloride levels

    Intervention Trial at the 20 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Chloride

    Assessment of circulatory electrolyte levels via collection of plasma chloride levels

    Intervention Trial at the 40 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Chloride

    Assessment of circulatory electrolyte levels via collection of plasma chloride levels

    Intervention Trial at the 60 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Chloride

    Assessment of circulatory electrolyte levels via collection of plasma chloride levels

    Intervention Trial at the 80 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Chloride

    Assessment of circulatory electrolyte levels via collection of plasma chloride levels

    Intervention Trial at the 130 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Chloride

    Assessment of circulatory electrolyte levels via collection of plasma chloride levels

    Intervention Trial at the 190 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Chloride

    Assessment of circulatory electrolyte levels via collection of plasma chloride levels

    Intervention Trial at the 220 minute mark

  • Systemic Electrolyte Levels - Change in Plasma Chloride

    Assessment of circulatory electrolyte levels via collection of plasma chloride levels

    Rehydration Protocol - 24 hours post-intervention

  • Systemic Osmotic Stress - Change in Plasma Osmolality

    Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels

    Phase-specific PRE Session

  • Systemic Osmotic Stress - Change in Plasma Osmolality

    Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels

    Intervention Trial at the -35 minute mark

  • Systemic Osmotic Stress - Change in Plasma Osmolality

    Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels

    Intervention Trial at the 0 minute mark

  • Systemic Osmotic Stress - Change in Plasma Osmolality

    Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels

    Intervention Trial at the 20 minute mark

  • Systemic Osmotic Stress - Change in Plasma Osmolality

    Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels

    Intervention Trial at the 40 minute mark

  • Systemic Osmotic Stress - Change in Plasma Osmolality

    Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels

    Intervention Trial at the 60 minute mark

  • Systemic Osmotic Stress - Change in Plasma Osmolality

    Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels

    Intervention Trial at the 80 minute mark

  • Systemic Osmotic Stress - Change in Plasma Osmolality

    Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels

    Intervention Trial at the 130 minute mark

  • Systemic Osmotic Stress - Change in Plasma Osmolality

    Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels

    Intervention Trial at the 190 minute mark

  • Systemic Osmotic Stress - Change in Plasma Osmolality

    Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels

    Intervention Trial at the 220 minute mark

  • Systemic Osmotic Stress - Change in Plasma Osmolality

    Assessment of circulatory osmotic stress levels via collection of plasma osmolality levels

    Rehydration Protocol - 24 hours post-intervention

  • Renal Function - Change in Acute Urinary Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels

    Phase-specific PRE Session

  • Renal Function - Change in 24-h Urinary Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels

    Phase-specific PRE Session

  • Renal Function - Change in Acute Urinary Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels

    Intervention Trial at the -45 minute mark

  • Renal Function - Change in Acute Urinary Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels

    Intervention Trial at the 0 minute mark

  • Renal Function - Change in Acute Urinary Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels

    Intervention Trial at the 40 minute mark

  • Renal Function - Change in Acute Urinary Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels

    Intervention Trial at the 80 minute mark

  • Renal Function - Change in Acute Urinary Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels

    Intervention Trial at the 220 minute mark

  • Renal Function - Change in Urinary Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels

    Rehydration Protocol - 3 hours post-intervention

  • Renal Function - Change in Urinary Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels

    Rehydration Protocol - 6 hours post-intervention

  • Renal Function - Change in Urinary Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels

    Rehydration Protocol - 15 hours post-intervention

  • Renal Function - Change in Urinary Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary creatinine levels

    Rehydration Protocol - 24 hours post-intervention

  • Renal Function - Change in Acute Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Phase-specific PRE Session

  • Renal Function - Change in 24-h Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Phase-specific PRE Session

  • Renal Function - Change in Acute Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Intervention Trial at the -45 minute mark

  • Renal Function - Change in Chronic Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Intervention Trial at the -45 minute mark

  • Renal Function - Change in Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Intervention Trial at the 0 minute mark

  • Renal Function - Change in Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Intervention Trial at the 40 minute mark

  • Renal Function - Change in Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Intervention Trial at the 80 minute mark

  • Renal Function - Change in Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Intervention Trial at the 220 minute mark

  • Renal Function - Change in Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Rehydration Protocol - 3 hours post-intervention

  • Renal Function - Change in Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Rehydration Protocol - 6 hours post-intervention

  • Renal Function - Change in Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Rehydration Protocol - 15 hours post-intervention

  • Renal Function - Change in Urinary BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary BUN levels

    Rehydration Protocol - 24 hours post-intervention

  • Renal Function - Change in Acute Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Phase-specific PRE Session

  • Renal Function - Change in 24-h Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Phase-specific PRE Session

  • Renal Function - Change in Acute Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Intervention Trial at the -45 minute mark

  • Renal Function - Change in 24-h Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Intervention Trial at the -45 minute mark

  • Renal Function - Change in Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Intervention Trial at the 0 minute mark

  • Renal Function - Change in Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Intervention Trial at the 40 minute mark

  • Renal Function - Change in Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Intervention Trial at the 80 minute mark

  • Renal Function - Change in Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Intervention Trial at the 220 minute mark

  • Renal Function - Change in Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Rehydration Protocol - 3 hours post-intervention

  • Renal Function - Change in Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Rehydration Protocol - 6 hours post-intervention

  • Renal Function - Change in Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Rehydration Protocol - 15 hours post-intervention

  • Renal Function - Change in Urinary IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary IGFBP7 levels

    Rehydration Protocol - 24 hours post-intervention

  • Renal Function - Change in Acute Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Phase-specific PRE Session

  • Renal Function - Change in 24-h Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Phase-specific PRE Session

  • Renal Function - Change in Acute Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Intervention Trial at the -45 minute mark

  • Renal Function - Change in 24-h Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Intervention Trial at the -45 minute mark

  • Renal Function - Change in Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Intervention Trial at the 0 minute mark

  • Renal Function - Change in Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Intervention Trial at the 40 minute mark

  • Renal Function - Change in Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Intervention Trial at the 80 minute mark

  • Renal Function - Change in Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Intervention Trial at the 220 minute mark

  • Renal Function - Change in Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Rehydration Protocol - 3 hours post-intervention

  • Renal Function - Change in Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Rehydration Protocol - 6 hours post-intervention

  • Renal Function - Change in Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Rehydration Protocol - 15 hours post-intervention

  • Renal Function - Change in Urinary TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of urinary TIMP2 levels

    Rehydration Protocol - 24 hours post-intervention

  • Renal Function - Change in Plasma Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma creatinine levels

    Phase-specific PRE Session

  • Renal Function - Change in Plasma Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma creatinine levels

    Intervention Trial at the -35 minute mark

  • Renal Function - Change in Plasma Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma creatinine levels

    Intervention Trial at the 0 minute mark

  • Renal Function - Change in Plasma Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma creatinine levels

    Intervention Trial at the 40 minute mark

  • Renal Function - Change in Plasma Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma creatinine levels

    Intervention Trial at the 80 minute mark

  • Renal Function - Change in Plasma Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma creatinine levels

    Intervention Trial at the 220 minute mark

  • Renal Function - Change in Plasma Creatinine Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma creatinine levels

    Rehydration Protocol - 24 hours post-intervention

  • Renal Function - Change in Plasma BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma BUN levels

    Phase-specific PRE Session

  • Renal Function - Change in Plasma BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma BUN levels

    Intervention Trial at the -35 minute mark

  • Renal Function - Change in Plasma BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma BUN levels

    Intervention Trial at the 0 minute mark

  • Renal Function - Change in Plasma BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma BUN levels

    Intervention Trial at the 40 minute mark

  • Renal Function - Change in Plasma BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma BUN levels

    Intervention Trial at the 80 minute mark

  • Renal Function - Change in Plasma BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma BUN levels

    Intervention Trial at the 220 minute mark

  • Renal Function - Change in Plasma BUN Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma BUN levels

    Rehydration Protocol - 24 hours post-intervention

  • Renal Function - Change in Plasma IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma IGFBP7 levels

    Phase-specific PRE Session

  • Renal Function - Change in Plasma IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma IGFBP7 levels

    Intervention Trial at -35 minute mark

  • Renal Function - Change in Plasma IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma IGFBP7 levels

    Intervention Trial at 0 minute mark

  • Renal Function - Change in Plasma IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma IGFBP7 levels

    Intervention Trial at 40 minute mark

  • Renal Function - Change in Plasma IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma IGFBP7 levels

    Intervention Trial at 80 minute mark

  • Renal Function - Change in Plasma IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma IGFBP7 levels

    Intervention Trial at 220 minute mark

  • Renal Function - Change in Plasma IGFBP7 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma IGFBP7 levels

    Rehydration Protocol - 24 hours post-intervention

  • Renal Function - Change in Plasma TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma TIMP2 levels

    Phase-specific PRE Session

  • Renal Function - Change in Plasma TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma TIMP2 levels

    Intervention Trial at the -35 minute mark

  • Renal Function - Change in Plasma TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma TIMP2 levels

    Intervention Trial at the 0 minute mark

  • Renal Function - Change in Plasma TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma TIMP2 levels

    Intervention Trial at the 40 minute mark

  • Renal Function - Change in Plasma TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma TIMP2 levels

    Intervention Trial at the 80 minute mark

  • Renal Function - Change in Plasma TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma TIMP2 levels

    Intervention Trial at the 220 minute mark

  • Renal Function - Change in Plasma TIMP2 Levels

    Assessment of renal function and potential sustainment of injury via collection of plasma TIMP2 levels

    Rehydration Protocol - 24 hours post-intervention

Secondary Outcomes (74)

  • Hydration Status - Change in Whole Blood Plasma Volume Shifts

    Phase-specific PRE Session

  • Hydration Status - Change in Whole Blood Plasma Volume Shifts

    Intervention Trial at the -35 minute mark

  • Hydration Status - Change in Whole Blood Plasma Volume Shifts

    Intervention Trial at the 0 minute mark

  • Hydration Status - Change in Whole Blood Plasma Volume Shifts

    Intervention Trial at the 20 minute mark

  • Hydration Status - Change in Whole Blood Plasma Volume Shifts

    Intervention Trial at the 40 minute mark

  • +69 more secondary outcomes

Study Arms (5)

PR Lotion Topical Solution

ACTIVE COMPARATOR

Dose Dependent Response: Different doses relative to the participant's body weight will be provided for provision onto the skin before beginning data collection procedures. The 'larger' dose will be composed of 0.8g/kg of the PR Lotion while the 'smaller' dose will be composed of 0.4g/kg of the PR Lotion. Participants will be instructed to apply the lotion primarily to their lower extremities and upper extremities as needed. This lotion will be applied once during the Intervention session of each phase completed and will remain on the skin for approximately 3.5 hours.

Other: PR Lotion - AMP Human Performance

Placebo Lotion Topical Solution

PLACEBO COMPARATOR

A dose of lotion relative to the participant's body weight will be provided for provision onto the skin before beginning data collection procedures. This dose will be approximately 0.8g/kg of the Placebo Lotion. Similar to the PR Lotion, participants will be instructed to apply the lotion primarily to their lower extremities and upper extremities as needed. This lotion will be applied once during the Intervention session of each phase completed and will remain on the skin for approximately 3.5 hours.

Other: Placebo Lotion

Hydration Status

EXPERIMENTAL

Participants will be asked to partake in 5 total Intervention trials. Upon arrival to each trial, the participant will be asked to complete an 18-24 fluid restriction protocol to ensure their arrival within a dehydrated state. Depending on the phase randomization assigned to each participant, they will either be provided fluids to consume that will bring them back to an estimated level of 1% dehydration (total of 3/5 trials completed) or they will not be given any fluids to consume during the duration of the trial (total 2/5 trials completed). Participants will be considered completed with project participation upon the completion of each of the five trials outlined.

Other: PR Lotion - AMP Human PerformanceOther: Placebo LotionOther: AminoVital - Rapid RecoveryOther: Placebo Supplement

aminoVITAL - Amino Acid Rehydration Supplement

ACTIVE COMPARATOR

Participants will be provided with 3 servings of a commercially available amino acid rehydration supplement for consumption after the completion of the dehydrated heat stress intervention. Participants will be instructed to consume each serving in a time-dependent manner over the 24-hour period after dismissal from the laboratory after completion of the Intervention session.

Other: AminoVital - Rapid Recovery

Placebo Drink Supplement Solution

PLACEBO COMPARATOR

Participants will be provided with 3 servings of a placebo rehydration supplement for consumption after the completion of the dehydrated heat stress intervention. Participants will be instructed to consume each serving in a time-dependent manner over the 24-hour period after dismissal from the laboratory after completion of the Intervention session.

Other: Placebo Supplement

Interventions

PR Lotion - AMP Human PerformanceOTHER

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. Other Names: NDC Code: 72358-101-01 NDC Code: 72358-101-02 NDC Code: 72358-101-03

Also known as: NDC Code: 72358-101-01, NDC Code: 72358-101-02, NDC Code: 72358-101-03
Hydration StatusPR Lotion Topical Solution
Placebo LotionOTHER

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.

Hydration StatusPlacebo Lotion Topical Solution
AminoVital - Rapid RecoveryOTHER

AminoVITAL Rapid Recovery is a commercially available supplement that is not currently regulated by the FDA but does complete both internal quality control and third-party testing for all of their products. AminoVITAL Rapid Recovery has been certified by the Banned Substance Control Group (BSCG; https://www.bscg.org/certified-drug- free-supplements/?AminoVITAL) and has been certified to be free of 496+ drugs including WADA Prohibited Substances as well as prescription, over the counter, and illicit drugs not banned in sport. AminoVITAL Rapid Recovery is safe to consume multiple times within a single day and has been found most effective when taken within 30 minutes of cessation of exercise. No known side effects are associated with the ingestion of aminoVITAL Rapid Recovery; however, side effects of amino acid toxicity include gastrointestinal distress, nausea and headache.

Hydration StatusaminoVITAL - Amino Acid Rehydration Supplement
Placebo SupplementOTHER

Supplement will be created by the aminoVITAL company and will include all ingredients similar to the commercially available Rapid Recovery product except for the exclusion of the amino acid blend.

Hydration StatusPlacebo Drink Supplement Solution

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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 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).
  • 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, integumentary, and/or thermoregulatory function (i.e. amphetamines, antihypertensives, anticholinergics, acetaminophen, NSAIDs, aspirin, and water pills).
  • Individuals who are taking any prescription medication for diabetes mellitus, Parkinson's disease, or kidney disease.
  • Individuals who have donated blood within the previous month.
  • Individuals who have an implanted pacemaker or internal defibrillator.
  • Individuals who report a history of claustrophobia
  • 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 and/or rehydration protocol measurements (i.e. creatine, sodium bicarbonate, potassium, magnesium, dandelion, vitamin B, protein powder, BCAAs, fish oil, multivitamins, soluble fiber, other natural diuretics) at time of testing.
  • Individuals who are suffering from a current musculoskeletal injury or active lesion of the skin that inhibits the participant's ability to complete all tasks required for participation.
  • Individuals who are allergic/sensitive to adhesive materials (i.e., medical tape)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korey Stringer Institute at the University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

HypernatremiaHeat Stress DisordersDehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

September 26, 2021

First Posted

October 26, 2021

Study Start

September 3, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

October 24, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)