Phase
Condition
Low Blood Pressure (Hypotension)
Treatment
Water
Oral Rehydration Solution (ORS)
Clinical Study ID
Ages 18-40 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant is 18 to 40 years of age.
Participant has a body mass index (BMI) ≥ 18 and ≤ 30 kg/m2
Participant reports having a moderate to heavy sweat rate when physically exerted orin extreme heat
Participant is male or non-pregnant, non-lactating female, at least 6 weekspostpartum prior to screening visit.
Participant has a systolic blood pressure <130 mm Hg and a diastolic blood pressure < 90 mm Hg without the use of anti-hypertensive medications.
Participant reports no predisposing cardiovascular conditions.
If female, participant has a regular menstrual cycle
Participant is willing to consume grape-flavored beverages during the study.
If participant is on chronic medication the dosage must be constant for at least 2months prior to enrollment and able to maintain medication, type and dose throughoutduration of study
Participant is weight-stable for the two months prior to screening visit
Participant has voluntarily signed and dated an informed consent form (ICF),approved by an IRB, and provided applicable privacy regulation authorization priorto any participation in the study
Participant has no known intolerance or allergy to ingredients in study products
Participant is willing to refrain from using saunas or hot tubs for the duration ofthe study
Participant is able and willing to follow study procedures and complete any forms orassessments needed during the study
Exclusion
Exclusion Criteria:
Participant is a current or recent (the past 8 weeks) participant in aweight-conscious sport such as but not limited to wrestling, powerlifting, boxing,rowing, gymnastics or any martial arts, with participation defined as ≥ 3x weeklytraining
Participant is currently, and for the past 4 weeks or longer: running >40 miles perweek on average, cycling >80 miles per week on average or swimming >20,000 yards perweek on average
Participant is participating in another study that has not been approved as aconcomitant study
Participant has used a sauna in the past 4 weeks
Participant uses any form of tobacco or nicotine, or other controlled substance notprescribed by a physician
Participant has previous history with heat illness or injury that resulted in avisit to a medical center in the past 12 months
Participant has an eating disorder, severe dementia or delirium, history ofsignificant neurological or psychiatric disorder, alcoholism, substance abuse orother conditions that may interfere with study product consumption or compliancewith study protocol procedures
Participant is currently taking or has taken antibiotics within 6 weeks ofenrollment
Participant is currently taking or has taken a diuretic within 1 week of enrollment
Participant has been diagnosed with the following:
Acute or chronic infections including but not restricted to respiratoryinfections, diarrhea, Hepatitis B or C, HIV infection or tuberculosis
Severe gastrointestinal disorders such as celiac disease, short bowel syndrome,pancreatic insufficiency, or cystic fibrosis
Metabolic [including diabetes], renal, hepatic, or respiratory disease
Active malignancy
Polycystic ovary disease
Any other clinically significant medical condition, which in the investigator'sopinion, makes him or her unsuitable for inclusion in the study
Study Design
Connect with a study center
University of Central Florida
Orlando, Florida 32816
United StatesSite Not Available
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