Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Healthy Blood Pressure.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUSANA Health Sciences
About this trial
This study is designed to evaluate the safety and tolerability of two distinct dietary supplement beverage formulations designed to maintain normal blood pressure. In this study, safety and tolerability will be assessed among otherwise healthy, normotensive individuals.
Eligibility criteria
Qualifiers
You are male or female between the ages of 18 and 50 (inclusive)
You are in generally good health and taking no medications known to treat or affect blood pressure (e.g., angiotensin converting enzyme (ACE) inhibitors, calcium channel blockers, diuretics)
You have a Body Mass Index of 18.5 to 30.0
You have a resting blood pressure of systolic blood pressure (SBP) of 90 - 120 mm Hg and a diastolic blood pressure (DBP) 60 - 80 mm Hg
Disqualifiers
You are pregnant, attempting to become pregnant, or are currently lactating
You currently use prescription or over-the-counter medications that may interfere with absorption of the test supplement or confound results (e.g., thiazide and loop diuretics for hypertension, corticosteroids)
You have clinically important gastrointestinal, renal, hepatic, cardiac, pulmonary, pancreatic, neurologic or biliary disorders or conditions. Individuals with type 1 or type 2 diabetes will be excluded from the study
You have illnesses or other medical conditions that will prevent or interfere with giving an informed consent, or with participation in the study.
Trial design
Treatments tested in this trial
- Treatment 1
- Treatment 2
- Placebo
Treatment groups
18 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov