Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Healthy Blood Pressure.
NCT ID: NCT06442293
Last Updated: 2024-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
18 participants
INTERVENTIONAL
2024-07-01
2024-08-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Placebo
a placebo (microcrystalline cellulose) identical in size, shape and color to the treatment
Placebo
a placebo supplement that is similar in appearance to treatment 1
Circulatory Beverage - low dose
A beverage containing natural ingredients at a low dose
Treatment 1
A dietary supplement containing beet root extract, arginine and citrulline
Circulatory Beverage - medium dose
A beverage containing natural ingredients at a medium dose
Treatment 1
A dietary supplement containing beet root extract, arginine and citrulline
Circulatory Beverage - high dose
A beverage containing natural ingredients at a high dose
Treatment 1
A dietary supplement containing beet root extract, arginine and citrulline
TCM Beverage - low dose
A traditional Chinese medicine-based beverage containing natural ingredients at a low dose
Treatment 2
A traditional Chinese medicine (TCM)-based dietary supplement containing chrysanthemum extract and eucommia bark extract
TCM Beverage - high dose
A traditional Chinese medicine-based beverage containing natural ingredients at a high dose
Treatment 2
A traditional Chinese medicine (TCM)-based dietary supplement containing chrysanthemum extract and eucommia bark extract
Interventions
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Treatment 1
A dietary supplement containing beet root extract, arginine and citrulline
Treatment 2
A traditional Chinese medicine (TCM)-based dietary supplement containing chrysanthemum extract and eucommia bark extract
Placebo
a placebo supplement that is similar in appearance to treatment 1
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
50 Years
ALL
Yes
Sponsors
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USANA Health Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Levy, PhD
Role: PRINCIPAL_INVESTIGATOR
USANA Health Sciences
Locations
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USANA Health Sciences
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Other Identifiers
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202401CT
Identifier Type: -
Identifier Source: org_study_id
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