TP1 for Dehydration

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of South Carolina, Columbia, SC
Dehydration+5 More
TP1 - Other
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

Dehydration lowers both physical and mental performance if it is severe enough. Performance declines are more pronounced in hot conditions or after prolonged strenuous activity such as exercise. Most individuals drink less than their sweat losses during activity, while some individuals overdrink and develop a sodium deficiency. Water and electrolyte balance must be restored as part of the recovery process after any activity that causes sweating. Plain water causes a decrease in plasma sodium concentration and osmolality, which reduces the desire to drink and increases urine production. Unless the volume ingested exceeds the loss, individuals are in net negative fluid balance throughout the recovery period due to urinary losses. When sodium and potassium are added to rehydration fluids, urine production is reduced in the hours following rehydration. Rehydration is only possible if a volume of fluid equal to or greater than the amount lost through sweat is consumed, together with adequate electrolytes. The test products for this study, TP1 and TP2, are novel hydration beverage formulas. They are an electrolyte drink mixture with five essential vitamins and three times more electrolytes than typical sports beverages. The test products create an osmotic force that permits water to be supplied to the bloodstream sooner in the digestive system by using a specific ratio of sodium, glucose, and potassium. This randomized, placebo-controlled, semi-blind, crossover study will evaluate the effects of the test products on rehydration in healthy adults.

Eligible Conditions

  • Rehydration
  • Exercise Performance
  • Dehydration
  • Exercise Recovery
  • Fluid Balance
  • Cognitive Performance

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Through study completion, an average of 8 weeks

Week 8
Exercise performance
Hydration status
Participant reported outcomes
Plasma electrolyte levels
Relative effects of dehydration and rehydration
Relative rehydration

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

TP2
1 of 3
TP1
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

16 Total Participants · 3 Treatment Groups

Primary Treatment: TP1 · Has Placebo Group · N/A

TP2
Other
Experimental Group · 1 Intervention: TP2 · Intervention Types: Other
TP1
Other
Experimental Group · 1 Intervention: TP1 · Intervention Types: Other
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 8 weeks
Closest Location: University of South Carolina · Columbia, SC
Photo of medical university of south carolina 1Photo of medical university of south carolina 2Photo of medical university of south carolina 3
2010First Recorded Clinical Trial
1 TrialsResearching Dehydration
81 CompletedClinical Trials

Who is running the clinical trial?

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.NETWORK
26 Previous Clinical Trials
1,523 Total Patients Enrolled
University of South CarolinaOTHER
173 Previous Clinical Trials
93,818 Total Patients Enrolled
1 Trials studying Dehydration
42 Patients Enrolled for Dehydration
Liquid I.V.Lead Sponsor
3 Previous Clinical Trials
71 Total Patients Enrolled
1 Trials studying Dehydration
16 Patients Enrolled for Dehydration
Sean Arent, PhDPrincipal InvestigatorUniversity of South Carolina

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a body mass index (BMI) between 17.0 and 29.
You have normal or acceptable vital signs (BP and HR) at screening.
You are sexually active but have not had sexual intercourse for at least 12 months.
You are between 18 and 49 years of age.
You are in good general health and can ingest the assigned amount of fluid at each visit.
You are willing to maintain the same level of physical activity throughout the study period.
You are able to maintain your exercise status at the beginning of the study.
You agree to use a condom or other acceptable method to prevent pregnancy throughout the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.