Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults

NCT ID: NCT06063655

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-07

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dehydration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A Randomized, Placebo Controlled, Semi-Blind, Crossover Study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Subjects will be assigned conditions via a code (A, B, C)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Water, Hydration Multiplier, Sugar-Free

Subjects will undergo three 90-min cycling bouts at 70-80% maximal hear rate, 86-89 degrees Fahrenheit, and approximately 50% relative humidity spaced 1-2 weeks apart. Subjects will be provided with a different test drink after each cycling bout at an amount equivalent to150% of sweat losses and evaluated for rehydration.

Subjects randomly assigned to this arm will be provided with the experimental/placebo conditions in the following order: water, Liquid IV Hydration Multiplier, and Liquid IV Sugar-Free Hydration Multiplier.

Group Type EXPERIMENTAL

Control: Water

Intervention Type DIETARY_SUPPLEMENT

Water will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV sugar-free hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV sugar-free hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Water, Sugar-Free, Hydration Multiplier

Subjects will undergo three 90-min cycling bouts at 70-80% maximal hear rate, 86-89 degrees Fahrenheit, and approximately 50% relative humidity spaced 1-2 weeks apart. Subjects will be provided with a different test drink after each cycling bout at an amount equivalent to150% of sweat losses and evaluated for rehydration.

Subjects randomly assigned to this arm will be provided with the experimental/placebo conditions in the following order: water, Liquid IV Sugar-Free Hydration Multiplier, and Liquid IV Hydration Multiplier.

Group Type EXPERIMENTAL

Control: Water

Intervention Type DIETARY_SUPPLEMENT

Water will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV sugar-free hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV sugar-free hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Hydration Multiplier, Sugar-Free, Water

Subjects will undergo three 90-min cycling bouts at 70-80% maximal hear rate, 86-89 degrees Fahrenheit, and approximately 50% relative humidity spaced 1-2 weeks apart. Subjects will be provided with a different test drink after each cycling bout at an amount equivalent to150% of sweat losses and evaluated for rehydration.

Subjects randomly assigned to this arm will be provided with the experimental/placebo conditions in the following order: Liquid IV Hydration Multiplier, Liquid IV Sugar-Free Hydration Multiplier, and water.

Group Type EXPERIMENTAL

Control: Water

Intervention Type DIETARY_SUPPLEMENT

Water will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV sugar-free hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV sugar-free hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Hydration Multiplier, Water, Sugar-Free

Subjects will undergo three 90-min cycling bouts at 70-80% maximal hear rate, 86-89 degrees Fahrenheit, and approximately 50% relative humidity spaced 1-2 weeks apart. Subjects will be provided with a different test drink after each cycling bout at an amount equivalent to150% of sweat losses and evaluated for rehydration.

Subjects randomly assigned to this arm will be provided with the experimental/placebo conditions in the following order: Liquid IV Hydration Multiplier, water, and Liquid IV Sugar-Free Hydration Multiplier.

Group Type EXPERIMENTAL

Control: Water

Intervention Type DIETARY_SUPPLEMENT

Water will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV sugar-free hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV sugar-free hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Sugar-Free, Water, Hydration Multiplier

Subjects will undergo three 90-min cycling bouts at 70-80% maximal hear rate, 86-89 degrees Fahrenheit, and approximately 50% relative humidity spaced 1-2 weeks apart. Subjects will be provided with a different test drink after each cycling bout at an amount equivalent to150% of sweat losses and evaluated for rehydration.

Subjects randomly assigned to this arm will be provided with the experimental/placebo conditions in the following order: Liquid IV Sugar-Free Hydration Multiplier, water, and Liquid IV Hydration Multiplier.

Group Type EXPERIMENTAL

Control: Water

Intervention Type DIETARY_SUPPLEMENT

Water will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV sugar-free hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV sugar-free hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Sugar-Free, Hydration Multiplier, Water

Subjects will undergo three 90-min cycling bouts at 70-80% maximal hear rate, 86-89 degrees Fahrenheit, and approximately 50% relative humidity spaced 1-2 weeks apart. Subjects will be provided with a different test drink after each cycling bout at an amount equivalent to150% of sweat losses and evaluated for rehydration.

Subjects randomly assigned to this arm will be provided with the experimental/placebo conditions in the following order: Liquid IV Sugar-Free Hydration Multiplier, Liquid IV Hydration Multiplier, and water.

Group Type EXPERIMENTAL

Control: Water

Intervention Type DIETARY_SUPPLEMENT

Water will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Liquid IV sugar-free hydration multiplier

Intervention Type DIETARY_SUPPLEMENT

Liquid IV sugar-free hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Control: Water

Water will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Intervention Type DIETARY_SUPPLEMENT

Liquid IV hydration multiplier

Liquid IV hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Intervention Type DIETARY_SUPPLEMENT

Liquid IV sugar-free hydration multiplier

Liquid IV sugar-free hydration multiplier will be provided to subject divided into 3 equal portions with each portion consumed over 10 minutes with 15 minutes between portions (rehydration period of 1 hour).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 beats per 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 surgery during study period
* Physically capable and willing to ingest the assigned amount of fluid while cycling and at rest for visits 3, 4, and 5
* Must be moderately trained; engage in moderate intensity, intermittent, or steady-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 their age and gender matched normative value per American College of Sports Medicine recommendations.
* Capable of completing 90 minutes of self-paced stationary cycling (\~70-80% max heart rate) 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 day prior 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 and during study period.
* Maintain diet, exercise, BMI, medication, and dietary supplements throughout study period as changes may alter hydration and electrolyte levels and result in changes to outcome measures.

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 localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
* Have an active or uncontrolled diseases or conditions
* Have had a current or previous Corona virus disease 2019 diagnosis in the three months prior to screening.
* Have any medical conditions that may impact ability to exercise or ability to ingest prescribed fluid volume as determined by the study nurse, including infection or illness
* Weighing less than 80 lbs at any visit; although very unlikely, we need to maintain this cut off, as too low a body mass is unhealthy.
* Has taken within 30 days or within seven half-lives (whichever is longer) of first test 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 study product), Laxatives, Diuretics, or Sports drinks (electrolyte drinks)
* received or use test product(s) in another research study in the 28 days prior to baseline visit (Familiarization, Visit/Visit 2), or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the 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 adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Memphis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Richard Bloomer

Dean of the College of Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard Bloomer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Memphis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PRO-FY2023-416

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Kids Rehydration During Exercise
NCT05989607 COMPLETED NA