An Evaluation of the Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Normal Blood Pressure in Normal, Healthy Individuals.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Aggregate Adverse Symptom Score
Study Overview
Brief Summary
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.
Detailed Description
The objective of this study is to evaluate the safety of 2 dietary supplement beverage formulations in healthy, normotensive individuals. The study period will be 29 days in length, during which we will monitor and catalogue the blood pressure (BP), heart rate (HR), comprehensive metabolic panel (CMP), complete blood count (CBC), as well as self-reported side effects of all subjects on a daily basis. Note that each beverage will be evaluated at multiple doses: Beverage 1 will be monitored at a low, medium and high dose, where the medium and high dose is quantitatively twice (2X) and thrice (3X) the low dose (1X), respectively. Similarly, we will evaluate Beverage 2 at a low dose and high dose where the high dose is quantitatively twice (2X) of the low dose (1X). A placebo treatment will also be incorporated into this study as well. As such, there will be 6 groups in this study. Three subjects will be assigned to each treatment group for a total of 18 subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •You are comfortable reading and speaking in English
- •You are fully able and willing to comply with the requirements of the study
- •You are fully able and willing to keep scheduled appointments
- •You have no known food allergies or intolerances
- •Female individuals will be asked to complete a pregnancy screening test.
Exclusion Criteria
- •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.
- •You have scheduling difficulties or lack of transportation that will prevent or interfere with their ability to attend all the necessary study visits.
- •You have participated as a subject in any other clinical study within 30 days of the screening visit.
- •You have a history of alcohol abuse or other substance abuse within the previous 2 years.
- •You are currently using tobacco products including chewing tobacco and cigarettes.
Outcomes
Primary Outcomes
Aggregate Adverse Symptom Score
Time Frame: 4 weeks
An assessment of adverse symptoms categorized as either respiratory, cardiovascular, neurological or gastrointestinal. If symptoms present, they are rated on a scale from 1 to 10, with indicating very mild symptoms and 10 indicating very severe symptoms.
Secondary Outcomes
- Blood pressure assessment(4 weeks)
- Heart rate monitoring(4 weeks)