Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults

Last updated: April 5, 2025
Sponsor: University of Memphis
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Treatment

Control: Water

Liquid IV hydration multiplier

Liquid IV sugar-free hydration multiplier

Clinical Study ID

NCT06063655
PRO-FY2023-416
  • Ages 18-49
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The electrolyte test products are composed of powder and provided in individual stick packs with 5 vitamins including Vitamins B3, B5, B6, B12 and Vitamin C. The products are gluten-, soy-, and dairy-free, and provide electrolytes at concentrations well below the daily value (DV). The DV tells us how much a particular nutrient in a serving of a food product contributes to a daily diet, based on a standard 2000 calorie diet. Despite what the name suggests, this product is taken orally, not intravenously. These packets contain a small percentage of the needed total daily electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity.

The products will be consumed following a 90-minute bout of cycling exercise at a moderate intensity of 70-80% max heart rate, at 30-32°C (86-89°F) and 50 ± 5% relative humidity. This same exercise duration and room temperature has been used in a recent study, which also utilized the same body temperature monitoring device as proposed in the present study. The purpose of the exercise bout is to simulate what many individuals are exposed to when exercising in the heat and to moderately dehydrate subjects, as would be the case during a moderate run or cycling event in exercise-trained individuals.

Subjects will report to the lab on three separate occasions to consume one of the 3 drinks (hydration multiplier, sugar-free hydration matrix, or water), in random order. The drinks will be consumed during the post-exercise period (30 minutes following the completion of exercise).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Body mass index (BMI) between 17.0-29.9 kg/m2 (not obese)

  • Resting heart rate less than 90 beats per minute; although, if less than 40 beatsper minute subject must get clearance from a medical professional

  • Not hypertensive (Systolic <140 mmHg and Diastolic <90 mmHg)

  • Have not had in the 3 months prior to screening or planning to have a major surgeryduring study period

  • Physically capable and willing to ingest the assigned amount of fluid while cyclingand at rest for visits 3, 4, and 5

  • Must be moderately trained; engage in moderate intensity, intermittent, orsteady-state exercise at least 3 days per week for at least one hour at a time.

  • Willing to maintain the same level of physical activity throughout the study period,except during the 24 hour period prior to each study visit.

  • Achieve a peak maximal oxygen consumption at screening that is at least 60% of theirage and gender matched normative value per American College of Sports Medicinerecommendations.

  • Capable of completing 90 minutes of self-paced stationary cycling (70-80% max heartrate) in a heated environmental chamber (30-32°C (86-89°F) with ~50% RH).

  • Can drink a minimum of 2.0 L fluid (if female) or 2.5 L fluid (if male) the dayprior to test visits

  • For visits 3-5, subjects must have a urine specific gravity less than 1.020.

  • For visit 3-5, subject must not have exercised within 24 hours of visit

  • Consume no more than two standard alcoholic drinks per day on a regular basis andduring study period.

  • Maintain diet, exercise, BMI, medication, and dietary supplements throughout studyperiod as changes may alter hydration and electrolyte levels and result in changesto outcome measures.

Exclusion

Exclusion Criteria:

  • If female, lactating, pregnant or planning to become pregnant during the study.

  • Have a known sensitivity or allergy to any of the study products

  • Have a history of diabetes

  • Have a history of known cardiovascular disease

  • Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea,unstable thyroid disease, immune disorder (i.e., HIV/AIDS), cancer (except localizedskin cancer without metastases or in situ cervical cancer within 5 years prior toscreening visit).

  • Have an active or uncontrolled diseases or conditions

  • Have had a current or previous Corona virus disease 2019 diagnosis in the threemonths prior to screening.

  • Have any medical conditions that may impact ability to exercise or ability to ingestprescribed fluid volume as determined by the study nurse, including infection orillness

  • Weighing less than 80 lbs at any visit; although very unlikely, we need to maintainthis cut off, as too low a body mass is unhealthy.

  • Has taken within 30 days or within seven half-lives (whichever is longer) of firsttest visit: selective serotonin uptake inhibitors (SSRI), Apremilast,caffeine-containing drugs, Corticosteroids (systemic use), Decongestants, Diuretics,Laxatives, Muscle relaxants, Opioid painkillers, Statins, Oral antibiotics

  • Has taken within 30 days of first test visit: Calcium, Dandelion, Lithium orotate,Potassium citrate, Watercress, Inhalables smokables, or the like cigarettes,vaporizers, water pipes, or cannabis

  • Has taken within 24 hours prior to test visit: Alcohol, Caffeine (including coffee,tea, energy drinks, etc. prohibited in the 12hrs prior to each dose of the studyproduct), Laxatives, Diuretics, or Sports drinks (electrolyte drinks)

  • 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 testproduct is deemed by the investigator to have lasting effects that might influencethe eligibility 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 adverselyaffect the participant's ability to complete the study or its measures or pose asignificant risk to the participant.

Study Design

Total Participants: 25
Treatment Group(s): 3
Primary Treatment: Control: Water
Phase:
Study Start date:
September 07, 2023
Estimated Completion Date:
December 30, 2025

Study Description

Maintaining adequate hydration is essential to optimal health, as well as athletic performance. When individuals exercise (in particular in a warm environment), they can lose excessive amounts of fluids along with necessary electrolytes (e.g., sodium, potassium, chloride) through sweating. With dehydration, individuals may feel sluggish and can experience impaired physical performance.

The use of electrolytes (sodium in particular) has been used for decades to aid athlete hydration and has led to the development of various sport drinks (e.g., Gatorade, Powerade) -which also include small amounts of carbohydrate.

This study will evaluate the hydration effects of two electrolyte products dissolved in water (Hydration Multiplier and Sugar-Free Hydration Multiplier) compared to a placebo (water). The nutrient composition of the Sugar-Free hydration Multiplier is similar to the Liquid IV Hydration Multiplier product currently on the market but without sugar content.

The electrolyte test products are composed of powder and provided in individual stick packs with 5 vitamins including Vitamins B3, B5, B6, B12 and Vitamin C. The products are gluten-, soy-, and dairy-free, and provide electrolytes at concentrations well below the daily value (DV). The DV tells us how much a particular nutrient in a serving of a food product contributes to a daily diet, based on a standard 2000 calorie diet. Despite what the name suggests, this product is taken orally, not intravenously. These packets contain a small percentage of the needed total daily electrolytes but adequate amounts to replace lost electrolytes as a result of physical activity.

The products will be consumed following a 90-minute bout of cycling exercise at a moderate intensity of 70-80% max heart rate, at 30-32°C (86-89°F) and 50 ± 5% relative humidity. This same exercise duration and room temperature has been used in a recent study, which also utilized the same body temperature monitoring device as proposed in the present study. The purpose of the exercise bout is to simulate what many individuals are exposed to when exercising in the heat and to moderately dehydrate subjects, as would be the case during a moderate run or cycling event in exercise-trained individuals.

Subjects will report to the lab on three separate occasions to consume one of the 3 drinks (hydration multiplier, sugar-free hydration matrix, or water), in random order. The drinks will be consumed during the post-exercise period (30 minutes following the completion of exercise).

This study design and outcomes have been similarly used in previous rehydration studies that utilized exercise in heat to induce ~2% body weight loss with different test products . This study will help further the knowledge on how different formulations of hydration beverages (e.g., different carbohydrate and electrolyte compositions) alter rehydration following exercise. It is hypothesized that both test products will provide improved rehydration above water alone during the post-exercise period. Moreover, it is believed that the sugar free product may improve hydration similar to the standard Hydration Multiplier.

Connect with a study center

  • Center for Nutraceutical and Dietary Supplement Research

    Memphis, Tennessee 38152
    United States

    Site Not Available

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