Phase
Condition
Low Blood Pressure (Hypotension)
Treatment
Control: Water
Liquid IV hydration multiplier
Liquid IV sugar-free hydration multiplier
Clinical Study ID
Ages 18-49 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 beatsper 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 surgeryduring study period
Physically capable and willing to ingest the assigned amount of fluid while cyclingand at rest for visits 3, 4, and 5
Must be moderately trained; engage in moderate intensity, intermittent, orsteady-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 theirage and gender matched normative value per American College of Sports Medicinerecommendations.
Capable of completing 90 minutes of self-paced stationary cycling (
70-80% max heartrate) 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 dayprior 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 andduring study period.
Maintain diet, exercise, BMI, medication, and dietary supplements throughout studyperiod as changes may alter hydration and electrolyte levels and result in changesto outcome measures.
Exclusion
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 localizedskin cancer without metastases or in situ cervical cancer within 5 years prior toscreening visit).
Have an active or uncontrolled diseases or conditions
Have had a current or previous Corona virus disease 2019 diagnosis in the threemonths prior to screening.
Have any medical conditions that may impact ability to exercise or ability to ingestprescribed fluid volume as determined by the study nurse, including infection orillness
Weighing less than 80 lbs at any visit; although very unlikely, we need to maintainthis cut off, as too low a body mass is unhealthy.
Has taken within 30 days or within seven half-lives (whichever is longer) of firsttest 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 studyproduct), Laxatives, Diuretics, or Sports drinks (electrolyte drinks)
received or use test product(s) in another research study in the 28 days prior tobaseline visit (Familiarization, Visit/Visit 2), or longer if the previous testproduct is deemed by the investigator to have lasting effects that might influencethe 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 adverselyaffect the participant's ability to complete the study or its measures or pose asignificant risk to the participant.
Study Design
Study Description
Connect with a study center
Center for Nutraceutical and Dietary Supplement Research
Memphis, Tennessee 38152
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.