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Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults

Primary Purpose

Dehydration

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control: Water
Liquid IV hydration multiplier
Liquid IV sugar-free hydration multiplier
Sponsored by
University of Memphis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dehydration

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Center for Nutraceutical and Dietary Supplement ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Water, Hydration Multiplier, Sugar-Free

Water, Sugar-Free, Hydration Multiplier

Hydration Multiplier, Sugar-Free, Water

Hydration Multiplier, Water, Sugar-Free

Sugar-Free, Water, Hydration Multiplier

Sugar-Free, Hydration Multiplier, Water

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Body weight
body weight will be measured using a digital scale
Body weight
body weight will be measured using a digital scale
Body weight
body weight will be measured using a digital scale
Body weight
body weight will be measured using a digital scale
Urine Volume
urine will be collected in a tray and then weighed on a digital scale
Urine Volume
urine will be collected in a tray and then weighed on a digital scale
Urine Volume
urine will be collected in a tray and then weighed on a digital scale
Urine Volume
urine will be collected in a tray and then weighed on a digital scale
Urine Volume
urine will be collected in a tray and then weighed on a digital scale
Urine Volume
urine will be collected in a tray and then weighed on a digital scale
Urine Volume
urine will be collected in a tray and then weighed on a digital scale
Urine osmolality
Osmolality will be determined from a urine sample collected in a tray
Urine osmolality
Osmolality will be determined from a urine sample collected in a tray
Urine osmolality
Osmolality will be determined from a urine sample collected in a tray
Urine osmolality
Osmolality will be determined from a urine sample collected in a tray
Urine osmolality
Osmolality will be determined from a urine sample collected in a tray
Urine osmolality
Osmolality will be determined from a urine sample collected in a tray
Urine osmolality
Osmolality will be determined from a urine sample collected in a tray
Urine specific gravity
specific gravity will be determined using a refractometer from a urine sample collected
Urine specific gravity
specific gravity will be determined using a refractometer from a urine sample collected
Urine specific gravity
specific gravity will be determined using a refractometer from a urine sample collected
Urine specific gravity
specific gravity will be determined using a refractometer from a urine sample collected
Urine specific gravity
specific gravity will be determined using a refractometer from a urine sample collected
Urine specific gravity
specific gravity will be determined using a refractometer from a urine sample collected
Urine specific gravity
specific gravity will be determined using a refractometer from a urine sample collected
Urine specific gravity
specific gravity will be determined using a refractometer from a urine sample collected
Plasma Osmolality
Blood will be collected to determine plasma osmolality
Electrolyte levels
electrolyte levels will be measured in blood
Percent plasma volume
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Plasma Osmolality
Blood will be collected to determine plasma osmolality
Electrolyte levels
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Percent plasma volume
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Plasma Osmolality
Blood will be collected to determine plasma osmolality
Electrolyte levels
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Percent plasma volume
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Plasma Osmolality
Blood will be collected to determine plasma osmolality
Electrolyte levels
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Percent plasma volume
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Plasma Osmolality
Blood will be collected to determine plasma osmolality
Electrolyte levels
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Percent plasma volume
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Plasma Osmolality
Blood will be collected to determine plasma osmolality
Electrolyte levels
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Percent plasma volume
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Plasma Osmolality
Blood will be collected to determine plasma osmolality
Electrolyte levels
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Percent plasma volume
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.

Secondary Outcome Measures

Body temperature
Body temperature will be monitored during cycling
Heart rate
Heart rate will be monitored during cycling
Rate of Perceived Exertion
Rate of Perceived Exertion using a Borg scale from 6 (easy) to 20 (maximal effort) will be reported during cycling
maximal oxygen consumption
maximal oxygen consumption will be determined via a cycling test
Height
Height will be measured using a stadiometer
Weight
Weight will be determined using a digital scale
Waist/Hip ratio
Waist/Hip ratio will be determined by measuring each circumference with a tape measure
Resting Diastolic Blood Pressure
Diastolic blood pressure will be measured after a 10 minute rest sitting using a digital machine
Resting Systolic Blood Pressure
Systolic blood pressure will be measured after a 10 minute rest sitting using a digital machine
Heart Rate
Heart Rate will be measured after a 10 minute rest sitting using a digital machine

Full Information

First Posted
September 22, 2023
Last Updated
September 29, 2023
Sponsor
University of Memphis
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1. Study Identification

Unique Protocol Identification Number
NCT06063655
Brief Title
Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults
Official Title
A Randomized, Placebo Controlled, Semi-Blind, Crossover Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Memphis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehydration

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A Randomized, Placebo Controlled, Semi-Blind, Crossover Study
Masking
Participant
Masking Description
Subjects will be assigned conditions via a code (A, B, C)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Water, Hydration Multiplier, Sugar-Free
Arm Type
Experimental
Arm Description
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.
Arm Title
Water, Sugar-Free, Hydration Multiplier
Arm Type
Experimental
Arm Description
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.
Arm Title
Hydration Multiplier, Sugar-Free, Water
Arm Type
Experimental
Arm Description
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.
Arm Title
Hydration Multiplier, Water, Sugar-Free
Arm Type
Experimental
Arm Description
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.
Arm Title
Sugar-Free, Water, Hydration Multiplier
Arm Type
Experimental
Arm Description
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.
Arm Title
Sugar-Free, Hydration Multiplier, Water
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control: Water
Intervention Description
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
Intervention Name(s)
Liquid IV hydration multiplier
Intervention Description
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
Intervention Name(s)
Liquid IV sugar-free hydration multiplier
Intervention Description
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).
Primary Outcome Measure Information:
Title
Body weight
Description
body weight will be measured using a digital scale
Time Frame
baseline (prior to cycling)
Title
Body weight
Description
body weight will be measured using a digital scale
Time Frame
0 minutes after 90-minute cycle bout
Title
Body weight
Description
body weight will be measured using a digital scale
Time Frame
30 minutes after cycling
Title
Body weight
Description
body weight will be measured using a digital scale
Time Frame
4 hours and 30 minutes after cycling
Title
Urine Volume
Description
urine will be collected in a tray and then weighed on a digital scale
Time Frame
baseline (prior to cycling)
Title
Urine Volume
Description
urine will be collected in a tray and then weighed on a digital scale
Time Frame
0 minutes after cycling
Title
Urine Volume
Description
urine will be collected in a tray and then weighed on a digital scale
Time Frame
30 minutes after cycling
Title
Urine Volume
Description
urine will be collected in a tray and then weighed on a digital scale
Time Frame
1 hour 30 minutes after cycling (following rehydration period)
Title
Urine Volume
Description
urine will be collected in a tray and then weighed on a digital scale
Time Frame
2 hours 30 minutes after cycling
Title
Urine Volume
Description
urine will be collected in a tray and then weighed on a digital scale
Time Frame
3 hours 30 minutes after cycling
Title
Urine Volume
Description
urine will be collected in a tray and then weighed on a digital scale
Time Frame
4 hours 30 minutes after cycling
Title
Urine osmolality
Description
Osmolality will be determined from a urine sample collected in a tray
Time Frame
baseline (prior to cycling)
Title
Urine osmolality
Description
Osmolality will be determined from a urine sample collected in a tray
Time Frame
0 minutes after cycling
Title
Urine osmolality
Description
Osmolality will be determined from a urine sample collected in a tray
Time Frame
30 minutes after cycling
Title
Urine osmolality
Description
Osmolality will be determined from a urine sample collected in a tray
Time Frame
1 hour 30 minutes after cycling (following rehydration period)
Title
Urine osmolality
Description
Osmolality will be determined from a urine sample collected in a tray
Time Frame
2 hour 30 minutes after cycling (following rehydration period)
Title
Urine osmolality
Description
Osmolality will be determined from a urine sample collected in a tray
Time Frame
3 hour 30 minutes after cycling (following rehydration period)
Title
Urine osmolality
Description
Osmolality will be determined from a urine sample collected in a tray
Time Frame
4 hour 30 minutes after cycling (following rehydration period)
Title
Urine specific gravity
Description
specific gravity will be determined using a refractometer from a urine sample collected
Time Frame
first morning urine (~2 hours before visit)
Title
Urine specific gravity
Description
specific gravity will be determined using a refractometer from a urine sample collected
Time Frame
baseline (before cycling)
Title
Urine specific gravity
Description
specific gravity will be determined using a refractometer from a urine sample collected
Time Frame
0 minutes after cycling
Title
Urine specific gravity
Description
specific gravity will be determined using a refractometer from a urine sample collected
Time Frame
30 minutes after cycling
Title
Urine specific gravity
Description
specific gravity will be determined using a refractometer from a urine sample collected
Time Frame
1 hour 30 minutes after cycling (following rehydration period)
Title
Urine specific gravity
Description
specific gravity will be determined using a refractometer from a urine sample collected
Time Frame
2 hour 30 minutes after cycling (following rehydration period)
Title
Urine specific gravity
Description
specific gravity will be determined using a refractometer from a urine sample collected
Time Frame
3 hour 30 minutes after cycling (following rehydration period)
Title
Urine specific gravity
Description
specific gravity will be determined using a refractometer from a urine sample collected
Time Frame
4 hour 30 minutes after cycling (following rehydration period)
Title
Plasma Osmolality
Description
Blood will be collected to determine plasma osmolality
Time Frame
baseline (before cycling)
Title
Electrolyte levels
Description
electrolyte levels will be measured in blood
Time Frame
baseline (before cycling)
Title
Percent plasma volume
Description
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Time Frame
baseline (before cycling)
Title
Plasma Osmolality
Description
Blood will be collected to determine plasma osmolality
Time Frame
30 minutes post cycling
Title
Electrolyte levels
Description
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Time Frame
30 minutes post cycling
Title
Percent plasma volume
Description
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Time Frame
30 minutes post cycling
Title
Plasma Osmolality
Description
Blood will be collected to determine plasma osmolality
Time Frame
60 minutes post cycling
Title
Electrolyte levels
Description
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Time Frame
60 minutes post cycling
Title
Percent plasma volume
Description
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Time Frame
60 minutes post cycling
Title
Plasma Osmolality
Description
Blood will be collected to determine plasma osmolality
Time Frame
120 minutes post cycling
Title
Electrolyte levels
Description
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Time Frame
120 minutes post cycling
Title
Percent plasma volume
Description
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Time Frame
120 minutes post cycling
Title
Plasma Osmolality
Description
Blood will be collected to determine plasma osmolality
Time Frame
150 minutes post cycling
Title
Electrolyte levels
Description
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Time Frame
150 minutes post cycling
Title
Percent plasma volume
Description
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Time Frame
150 minutes post cycling
Title
Plasma Osmolality
Description
Blood will be collected to determine plasma osmolality
Time Frame
210 minutes post cycling
Title
Electrolyte levels
Description
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Time Frame
210 minutes post cycling
Title
Percent plasma volume
Description
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Time Frame
210 minutes post cycling
Title
Plasma Osmolality
Description
Blood will be collected to determine plasma osmolality
Time Frame
270 minutes post cycling
Title
Electrolyte levels
Description
electrolyte levels (Sodium, potassium, chloride, and carbon dioxide total) will be measured in blood (millimoles per liter)
Time Frame
270 minutes post cycling
Title
Percent plasma volume
Description
Percent plasma volume will be determined by measuring hematocrit and hemoglobin in blood.
Time Frame
270 minutes post cycling
Secondary Outcome Measure Information:
Title
Body temperature
Description
Body temperature will be monitored during cycling
Time Frame
Every 10 minutes during cycling
Title
Heart rate
Description
Heart rate will be monitored during cycling
Time Frame
Every 10 minutes during cycling
Title
Rate of Perceived Exertion
Description
Rate of Perceived Exertion using a Borg scale from 6 (easy) to 20 (maximal effort) will be reported during cycling
Time Frame
Every 10 minutes during cycling
Title
maximal oxygen consumption
Description
maximal oxygen consumption will be determined via a cycling test
Time Frame
At screening
Title
Height
Description
Height will be measured using a stadiometer
Time Frame
At screening
Title
Weight
Description
Weight will be determined using a digital scale
Time Frame
At screening
Title
Waist/Hip ratio
Description
Waist/Hip ratio will be determined by measuring each circumference with a tape measure
Time Frame
At screening
Title
Resting Diastolic Blood Pressure
Description
Diastolic blood pressure will be measured after a 10 minute rest sitting using a digital machine
Time Frame
At screening
Title
Resting Systolic Blood Pressure
Description
Systolic blood pressure will be measured after a 10 minute rest sitting using a digital machine
Time Frame
At screening
Title
Heart Rate
Description
Heart Rate will be measured after a 10 minute rest sitting using a digital machine
Time Frame
At screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jacquelyn Pence, PhD
Phone
901-678-1547
Email
jpence1@memphis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Bloomer, PhD
Organizational Affiliation
University of Memphis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Nutraceutical and Dietary Supplement Research
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38152
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackie Pence, Ph.D.
Phone
901-678-1547
Email
jpence1@memphis.edu
First Name & Middle Initial & Last Name & Degree
Richard J Bloomer, Ph.D.

12. IPD Sharing Statement

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Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults

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