Clinical Trial to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Healthy Adults

Last updated: January 23, 2023
Sponsor: Liquid I.V.
Overall Status: Completed

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Brain Function

Treatment

N/A

Clinical Study ID

NCT05428761
SOW4
  • Ages 18-49
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy adult male and female participants who are between 18 and 49 years of age (inclusive).
  • Are in good general health (no active or uncontrolled diseases or conditions) and caningest the assigned amount of fluid at each visit.
  • Have a body mass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive).
  • Exercise regularly as per physical activity guidelines for Americans [structuredexercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulativeminutes of exercise per week (high-end)] and willing to maintain the same level ofphysical activity throughout the study period.
  • Can maintain their exercise status at the beginning of the study throughout the studyperiod.
  • Can achieve a peak VO2 at screening that is at least 60% of their age and gendermatched normative value per American College of Sports Medicine recommendations.
  • Have normal or acceptable to to the investigator vital signs (BP and HR) at screening.
  • Individuals with childbearing potential:
  • Agree to practice an acceptable form of birth control for a certain timeframe prior tothe first dose of study product and throughout the study, including:
  1. use for at least three months prior to the first dose of study product: hormonalcontraceptives including oral contraceptives, hormone birth control patch (e.g.,Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectablecontraceptives (e.g., Depo-Provera, Lunelle), hormonal intrauterine devices (e.g., Mirena), or hormone implant (e.g., Norplant System); or
  2. use for at least one month prior to the first dose of study product:double-barrier method, non-hormonal intrauterine devices (i.e., copper), orcomplete abstinence from sexual intercourse that can result in pregnancy; or
  3. vasectomy of partner at least six months prior to the first dose of studyproduct.
  • Individuals with the potential to impregnate others:
  • Agree to use condom or other acceptable methods to prevent pregnancy throughout thestudy.
  • Complete abstinence from sexual intercourse that can result in pregnancy is alsoacceptable.
  • Able to agree to the requirements and restrictions of this study, willing to givevoluntary consent, able to understand and read the questionnaires, and carry out allstudy-related procedures.

Exclusion

Exclusion Criteria:

  • Female participants who are lactating, pregnant or planning to become pregnant duringthe study. Carry a diagnosis of diabetes.
  • Weigh less than or equal to 80 pounds at any visits.
  • Answer "yes" to any of the questions asked on the screening questionnaire (Appendix 10.2.1).
  • Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea,unstable thyroid disease, major affective disorder, psychiatric disorder that requiredhospitalization in the prior year, immune disorder (i.e., HIV/AIDS), cancer (exceptlocalized skin cancer without metastases or in situ cervical cancer within 5 yearsprior to screening visit).
  • Use any dietary supplements that may impact hydration status within the 30 days priorto the baseline visit (Familiarization Trial/Visit 2).
  • Participants must observe a 30-day washout period of no supplementation to beeligible. Consume more than two standard alcoholic drinks per day.
  • Use of inhalables, smokables, or the like (e.g., cigarettes, vaporizers, water pipes,or cannabis) within 30 days prior to the first dose of the study product or for theduration of the study.
  • Have a medical condition that may impact ability to exercise or ability to ingestprescribed fluid volume. Smoking tobacco products.
  • Have a history of alcohol or substance abuse in the 12 months prior to the screeningvisit.
  • Are cognitively impaired and/or unable to give informed consent. Have a knownsensitivity, intolerability, or allergy to any of the study products or theirexcipients, or any of the rescue medications.
  • Have a current or previous diagnosis with COVID-19 in the three months prior toscreening.
  • Have had major surgery three months prior to screening or have a planned major surgeryduring the course of the study.
  • Have received or use test product(s) in another research study in the 28 days prior tobaseline visit (Familiarization Visit/Visit 2), or longer if the previous test productis deemed by the investigator to have lasting effects that might influence theeligibility criteria or outcomes of the current study.
  • Have any other active or unstable medical conditions or use medications, supplements,or therapies that, in the opinion of the investigator, may adversely affect theparticipant's ability to complete the study or its measures or pose a significant riskto the participant.

Study Design

Total Participants: 16
Study Start date:
August 01, 2022
Estimated Completion Date:
January 01, 2023

Connect with a study center

  • University of South Carolina

    Columbia, South Carolina 29208
    United States

    Site Not Available

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