Clinical trial NCT06063655: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dehydration
Lead sponsor: University of Memphis
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A Randomized, Placebo Controlled, Semi-Blind, Crossover Study
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Body weight
timeFrame: baseline (prior to cycling)
measure: Body weight
timeFrame: 0 minutes after 90-minute cycle bout
measure: Body weight
timeFrame: 30 minutes after cycling
measure: Body weight
timeFrame: 4 hours and 30 minutes after cycling
measure: Urine Volume
timeFrame: baseline (prior to cycling)
measure: Urine Volume
timeFrame: 0 minutes after cycling
measure: Urine Volume
timeFrame: 30 minutes after cycling
measure: Urine Volume
timeFrame: 1 hour 30 minutes after cycling (following rehydration period)
measure: Urine Volume
timeFrame: 2 hours 30 minutes after cycling
measure: Urine Volume
timeFrame: 3 hours 30 minutes after cycling
measure: Urine Volume
timeFrame: 4 hours 30 minutes after cycling
measure: Urine osmolality
timeFrame: baseline (prior to cycling)
measure: Urine osmolality
timeFrame: 0 minutes after cycling
measure: Urine osmolality
timeFrame: 30 minutes after cycling
measure: Urine osmolality
timeFrame: 1 hour 30 minutes after cycling (following rehydration period)
measure: Urine osmolality
timeFrame: 2 hour 30 minutes after cycling (following rehydration period)
measure: Urine osmolality
timeFrame: 3 hour 30 minutes after cycling (following rehydration period)
measure: Urine osmolality
timeFrame: 4 hour 30 minutes after cycling (following rehydration period)
measure: Urine specific gravity
timeFrame: first morning urine (~2 hours before visit)
measure: Urine specific gravity
timeFrame: baseline (before cycling)
measure: Urine specific gravity
timeFrame: 0 minutes after cycling
measure: Urine specific gravity
timeFrame: 30 minutes after cycling
measure: Urine specific gravity
timeFrame: 1 hour 30 minutes after cycling (following rehydration period)
measure: Urine specific gravity
timeFrame: 2 hour 30 minutes after cycling (following rehydration period)
measure: Urine specific gravity
timeFrame: 3 hour 30 minutes after cycling (following rehydration period)
measure: Urine specific gravity
timeFrame: 4 hour 30 minutes after cycling (following rehydration period)
measure: Plasma Osmolality
timeFrame: baseline (before cycling)
measure: Electrolyte levels
timeFrame: baseline (before cycling)
measure: Percent plasma volume
timeFrame: baseline (before cycling)
measure: Plasma Osmolality
timeFrame: 30 minutes post cycling
measure: Electrolyte levels
timeFrame: 30 minutes post cycling
measure: Percent plasma volume
timeFrame: 30 minutes post cycling
measure: Plasma Osmolality
timeFrame: 60 minutes post cycling
measure: Electrolyte levels
timeFrame: 60 minutes post cycling
measure: Percent plasma volume
timeFrame: 60 minutes post cycling
measure: Plasma Osmolality
timeFrame: 120 minutes post cycling
measure: Electrolyte levels
timeFrame: 120 minutes post cycling
measure: Percent plasma volume
timeFrame: 120 minutes post cycling
measure: Plasma Osmolality
timeFrame: 150 minutes post cycling
measure: Electrolyte levels
timeFrame: 150 minutes post cycling
measure: Percent plasma volume
timeFrame: 150 minutes post cycling
measure: Plasma Osmolality
timeFrame: 210 minutes post cycling
measure: Electrolyte levels
timeFrame: 210 minutes post cycling
measure: Percent plasma volume
timeFrame: 210 minutes post cycling
measure: Plasma Osmolality
timeFrame: 270 minutes post cycling
measure: Electrolyte levels
timeFrame: 270 minutes post cycling
measure: Percent plasma volume
timeFrame: 270 minutes post cycling
Secondary outcomes:
measure: Body temperature
timeFrame: Every 10 minutes during cycling
measure: Heart rate
timeFrame: Every 10 minutes during cycling
measure: Rate of Perceived Exertion
timeFrame: Every 10 minutes during cycling
measure: maximal oxygen consumption
timeFrame: At screening
measure: Height
timeFrame: At screening
measure: Weight
timeFrame: At screening
measure: Waist/Hip ratio
timeFrame: At screening
measure: Resting Diastolic Blood Pressure
timeFrame: At screening
measure: Resting Systolic Blood Pressure
timeFrame: At screening
measure: Heart Rate
timeFrame: At screening
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Center for Nutraceutical and Dietary Supplement Research
state: Tennessee
Study officials:
affiliation: University of Memphis
name: Richard Bloomer, PhD
role: PRINCIPAL_INVESTIGATOR
References: