Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults

Dehydration Clinical Trial

Official title:

A Randomized, Placebo Controlled, Semi-Blind, Crossover Study to Evaluate the Effects of Two Novel Hydration Beverage Formulas on Rehydration in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06063655
• Other study ID #: PRO-FY2023-416
• Status: Recruiting
• Phase: N/A
• Start date: September 7, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: September 2023
• Source: University of Memphis
• Contact: Jacquelyn Pence, PhD
• Phone: 901-678-1547
• Email: jpence1[@]memphis.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dehydration

Intervention

Dietary Supplement:
• 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).
• 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).
• 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).

Locations

Country	Name	City	State
United States	Center for Nutraceutical and Dietary Supplement Research	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Memphis

Country where clinical trial is conducted

United States, 

Outcome

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