Health TrialsbyHealthPanel

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

ConditionsSafety IssuesTolerance
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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Treatment 1

    Dietary supplement

    A dietary supplement containing beet root extract, arginine and citrulline

  • Treatment 2

    Dietary supplement

    A traditional Chinese medicine (TCM)-based dietary supplement containing chrysanthemum extract and eucommia bark extract

  • Placebo

    Dietary supplement

    a placebo supplement that is similar in appearance to treatment 1

Treatment groups

18 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: PlaceboPlacebo comparator 1 intervention
Group B: Circulatory Beverage - low doseExperimental treatment 1 intervention
Group C: Circulatory Beverage - medium doseExperimental treatment 1 intervention
Group D: Circulatory Beverage - high doseExperimental treatment 1 intervention
Group E: TCM Beverage - low doseExperimental treatment 1 intervention
Group F: TCM Beverage - high doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Aggregate Adverse Symptom Score

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.

Time frame
4 weeks

Secondary outcomes

1

Blood pressure assessment

An assessment of subjects' blood pressure throughout the 4-week study period.

Time frame
4 weeks
2

Heart rate monitoring

An assessment of subjects' heart rate throughout the 4-week study period.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

USANA Health Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: