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

Launched by USANA HEALTH SCIENCES · Jun 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and tolerability of two different dietary supplement beverages that aim to help maintain healthy blood pressure levels. The study will involve healthy adults aged 18 to 50 who do not take any medications that could affect blood pressure. Participants will need to have a healthy body weight and normal blood pressure readings, and they should not have any serious medical conditions that could interfere with the study.

If you decide to participate, you can expect to drink the supplement beverages and attend scheduled visits for follow-up. The researchers will monitor how well you tolerate the drinks and check for any safety issues. It’s important to note that if you’re pregnant, trying to become pregnant, or have certain health conditions, you may not be eligible for this study. This trial is not yet recruiting participants, but it aims to gather valuable information about how these supplements affect blood pressure in healthy individuals.

Gender

ALL

Eligibility criteria

• 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.