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

An Evaluation of the Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Normal Blood Pressure in Normal, Healthy Individuals.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tolerance; Safety Issues
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Treatment 1; Dietary supplement: Treatment 2

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 Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mark Levy, PhD; Phone Number: (801) 954-7783; Email: mark.levy@usanainc.com
• Study Contact Backup: Name: Rolando Maddela, MPH; Phone Number: (801) 954-7568; Email: rolando.maddela@usanainc.com

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84120
      • USANA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; a placebo (microcrystalline cellulose) identical in size, shape and color to the treatment	Dietary supplement: Placebo; a placebo supplement that is similar in appearance to treatment 1
Experimental: Circulatory Beverage - low dose; A beverage containing natural ingredients at a low dose	Dietary supplement: Treatment 1; A dietary supplement containing beet root extract, arginine and citrulline
Experimental: Circulatory Beverage - medium dose; A beverage containing natural ingredients at a medium dose	Dietary supplement: Treatment 1; A dietary supplement containing beet root extract, arginine and citrulline
Experimental: Circulatory Beverage - high dose; A beverage containing natural ingredients at a high dose	Dietary supplement: Treatment 1; A dietary supplement containing beet root extract, arginine and citrulline
Experimental: TCM Beverage - low dose; A traditional Chinese medicine-based beverage containing natural ingredients at a low dose	Dietary supplement: Treatment 2; A traditional Chinese medicine (TCM)-based dietary supplement containing chrysanthemum extract and eucommia bark extract
Experimental: TCM Beverage - high dose; A traditional Chinese medicine-based beverage containing natural ingredients at a high dose	Dietary supplement: Treatment 2; A traditional Chinese medicine (TCM)-based dietary supplement containing chrysanthemum extract and eucommia bark extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure assessment	An assessment of subjects' blood pressure throughout the 4-week study period.	4 weeks
Heart rate monitoring	An assessment of subjects' heart rate throughout the 4-week study period.	4 weeks

Collaborators and Investigators

• Sponsor: USANA Health Sciences
• Investigators: Principal Investigator: Mark Levy, PhD, USANA Health Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: June 2, 2024
• First Posted (Actual): June 4, 2024

Study Record Updates

• Last Update Posted (Actual): June 4, 2024
• Last Update Submitted That Met QC Criteria: June 2, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 202401CT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No