Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults

NCT06063655 | Active Not Recruiting

• 1 other identifier: PRO-FY2023-416
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dehydration

Outcome Measures

Primary Outcomes (47)

• Body weight

  body weight will be measured using a digital scale

  baseline (prior to cycling)

• Body weight

  body weight will be measured using a digital scale

  0 minutes after 90-minute cycle bout

• Body weight

  body weight will be measured using a digital scale

  30 minutes after cycling

• Body weight

  body weight will be measured using a digital scale

  4 hours and 30 minutes after cycling

• Urine Volume

  urine will be collected in a tray and then weighed on a digital scale

  baseline (prior to cycling)

• Urine Volume

  urine will be collected in a tray and then weighed on a digital scale

  0 minutes after cycling

• Urine Volume

  urine will be collected in a tray and then weighed on a digital scale

  30 minutes after cycling

• Urine Volume

  urine will be collected in a tray and then weighed on a digital scale

  1 hour 30 minutes after cycling (following rehydration period)

• Urine Volume

  urine will be collected in a tray and then weighed on a digital scale

  2 hours 30 minutes after cycling

• Urine Volume

  urine will be collected in a tray and then weighed on a digital scale

  3 hours 30 minutes after cycling

• Urine Volume

  urine will be collected in a tray and then weighed on a digital scale

  4 hours 30 minutes after cycling

• Urine osmolality

  Osmolality will be determined from a urine sample collected in a tray

  baseline (prior to cycling)

• Urine osmolality

  Osmolality will be determined from a urine sample collected in a tray

  0 minutes after cycling

• Urine osmolality

  Osmolality will be determined from a urine sample collected in a tray

  30 minutes after cycling

• Urine osmolality

  Osmolality will be determined from a urine sample collected in a tray

  1 hour 30 minutes after cycling (following rehydration period)

• Urine osmolality

  Osmolality will be determined from a urine sample collected in a tray

  2 hour 30 minutes after cycling (following rehydration period)

• Urine osmolality

  Osmolality will be determined from a urine sample collected in a tray

  3 hour 30 minutes after cycling (following rehydration period)

• Urine osmolality

  Osmolality will be determined from a urine sample collected in a tray

  4 hour 30 minutes after cycling (following rehydration period)

• Urine specific gravity

  specific gravity will be determined using a refractometer from a urine sample collected

  first morning urine (~2 hours before visit)

• Urine specific gravity

  specific gravity will be determined using a refractometer from a urine sample collected

  baseline (before cycling)

• Urine specific gravity

  specific gravity will be determined using a refractometer from a urine sample collected

  0 minutes after cycling

• Urine specific gravity

  specific gravity will be determined using a refractometer from a urine sample collected

  30 minutes after cycling

• Urine specific gravity

  specific gravity will be determined using a refractometer from a urine sample collected

  1 hour 30 minutes after cycling (following rehydration period)

• Urine specific gravity

  specific gravity will be determined using a refractometer from a urine sample collected

  2 hour 30 minutes after cycling (following rehydration period)

• Urine specific gravity

  specific gravity will be determined using a refractometer from a urine sample collected

  3 hour 30 minutes after cycling (following rehydration period)

• Urine specific gravity

  specific gravity will be determined using a refractometer from a urine sample collected

  4 hour 30 minutes after cycling (following rehydration period)

• Plasma Osmolality

  Blood will be collected to determine plasma osmolality

  baseline (before cycling)

• Electrolyte levels

  electrolyte levels will be measured in blood

  baseline (before cycling)

• Percent plasma volume

  Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.

  baseline (before cycling)

• Plasma Osmolality

  Blood will be collected to determine plasma osmolality

  30 minutes post cycling

• Electrolyte levels

  electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)

  30 minutes post cycling

• Percent plasma volume

  Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.

  30 minutes post cycling

• Plasma Osmolality

  Blood will be collected to determine plasma osmolality

  60 minutes post cycling

• Electrolyte levels

  electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)

  60 minutes post cycling

• Percent plasma volume

  Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.

  60 minutes post cycling

• Plasma Osmolality

  Blood will be collected to determine plasma osmolality

  120 minutes post cycling

• Electrolyte levels

  electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)

  120 minutes post cycling

• Percent plasma volume

  Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.

  120 minutes post cycling

• Plasma Osmolality

  Blood will be collected to determine plasma osmolality

  150 minutes post cycling

• Electrolyte levels

  electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)

  150 minutes post cycling

• Percent plasma volume

  Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.

  150 minutes post cycling

• Plasma Osmolality

  Blood will be collected to determine plasma osmolality

  210 minutes post cycling

• Electrolyte levels

  electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)

  210 minutes post cycling

• Percent plasma volume

  Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.

  210 minutes post cycling

• Plasma Osmolality

  Blood will be collected to determine plasma osmolality

  270 minutes post cycling

• Electrolyte levels

  electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)

  270 minutes post cycling

• Percent plasma volume

  Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.

  270 minutes post cycling

Secondary Outcomes (10)

• Body temperature

  Every 10 minutes during cycling

• Heart rate

  Every 10 minutes during cycling

• Rate of Perceived Exertion

  Every 10 minutes during cycling

• maximal oxygen consumption

  At screening

• Height

  At screening

Study Arms (6)

Water, Hydration Multiplier, Sugar-Free

EXPERIMENTAL

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.

Dietary Supplement: Control: Water; Dietary Supplement: Liquid IV hydration multiplier; Dietary Supplement: Liquid IV sugar-free hydration multiplier

Water, Sugar-Free, Hydration Multiplier

EXPERIMENTAL

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.

Dietary Supplement: Control: Water; Dietary Supplement: Liquid IV hydration multiplier; Dietary Supplement: Liquid IV sugar-free hydration multiplier

Hydration Multiplier, Sugar-Free, Water

EXPERIMENTAL

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.

Dietary Supplement: Control: Water; Dietary Supplement: Liquid IV hydration multiplier; Dietary Supplement: Liquid IV sugar-free hydration multiplier

Hydration Multiplier, Water, Sugar-Free

EXPERIMENTAL

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.

Dietary Supplement: Control: Water; Dietary Supplement: Liquid IV hydration multiplier; Dietary Supplement: Liquid IV sugar-free hydration multiplier

Sugar-Free, Water, Hydration Multiplier

EXPERIMENTAL

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.

Dietary Supplement: Control: Water; Dietary Supplement: Liquid IV hydration multiplier; Dietary Supplement: Liquid IV sugar-free hydration multiplier

Sugar-Free, Hydration Multiplier, Water

EXPERIMENTAL

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.

Dietary Supplement: Control: Water; Dietary Supplement: Liquid IV hydration multiplier; Dietary Supplement: Liquid IV sugar-free hydration multiplier

Interventions

Control: Water 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).

Hydration Multiplier, Sugar-Free, Water; Hydration Multiplier, Water, Sugar-Free; Sugar-Free, Hydration Multiplier, Water; Sugar-Free, Water, Hydration Multiplier; Water, Hydration Multiplier, Sugar-Free; Water, Sugar-Free, Hydration Multiplier

Liquid IV hydration multiplier 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).

Hydration Multiplier, Sugar-Free, Water; Hydration Multiplier, Water, Sugar-Free; Sugar-Free, Hydration Multiplier, Water; Sugar-Free, Water, Hydration Multiplier; Water, Hydration Multiplier, Sugar-Free; Water, Sugar-Free, Hydration Multiplier

Liquid IV sugar-free hydration multiplier 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; Hydration Multiplier, Water, Sugar-Free; Sugar-Free, Hydration Multiplier, Water; Sugar-Free, Water, Hydration Multiplier; Water, Hydration Multiplier, Sugar-Free; Water, Sugar-Free, Hydration Multiplier

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Memphis: lead

Study Sites (1)

Center for Nutraceutical and Dietary Supplement Research

Memphis, Tennessee, 38152, United States

Location

MeSH Terms

Conditions

Dehydration

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Bloomer, PhD

  University of Memphis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be assigned conditions via a code (A, B, C)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the College of Health Sciences

Model Details: A Randomized, Placebo Controlled, Semi-Blind, Crossover Study

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 2, 2023
• Study Start: September 7, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

US (1)