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Safety of Dietary Supplements for Blood Pressure

This study is testing the safety of two different dietary supplement beverages designed to help maintain healthy blood pressure. One beverage contains beet root extract, arginine, and citrulline. The other is a traditional Chinese medicine (TCM)-based supplement with chrysanthemum extract and eucommia bark extract. You may be able to join if you are a healthy adult between 18 and 50 years old, not taking blood pressure medications, and have a BMI between 18.5 and 30. The main goal is to see if these supplements cause any side effects over four weeks. The current recruitment status is unclear.

Study design
This interventional study will assign 18 participants to one of six groups, including different doses of the two supplements and a placebo. It is not specified if the study is randomized or blinded.
What's involved
You would participate for 29 days, during which your blood pressure, heart rate, and blood tests (comprehensive metabolic panel, complete blood count) will be monitored daily. You will also report any side effects.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be measured at 4 weeks, which is the end of the study period.

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NCT06442293

Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Healthy Blood Pressure.

UNKNOWN
NAAges 18–50Interventional
USANA Health Sciences
~18 participants
Updated 2024-06-04 on ClinicalTrials.gov
What's tested:Treatment 1Treatment 2Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Aggregate Adverse Symptom Score
Measured over 4 weeks

Conditions

Safety Issues
Tolerance

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Utah1

Study leadership

  • Mark Levy, PhD · PRINCIPAL_INVESTIGATOR · USANA Health Sciences

Who to contact

Mark Levy, PhD
[email protected]
(801) 954-7783
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Aggregate Adverse Symptom Score4 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.