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

NCT ID: NCT06442293

Last Updated: 2024-06-04

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-08-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Safety Issues Tolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

single blind, placebo controlled
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

a placebo (microcrystalline cellulose) identical in size, shape and color to the treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

a placebo supplement that is similar in appearance to treatment 1

Circulatory Beverage - low dose

A beverage containing natural ingredients at a low dose

Group Type EXPERIMENTAL

Treatment 1

Intervention Type DIETARY_SUPPLEMENT

A dietary supplement containing beet root extract, arginine and citrulline

Circulatory Beverage - medium dose

A beverage containing natural ingredients at a medium dose

Group Type EXPERIMENTAL

Treatment 1

Intervention Type DIETARY_SUPPLEMENT

A dietary supplement containing beet root extract, arginine and citrulline

Circulatory Beverage - high dose

A beverage containing natural ingredients at a high dose

Group Type EXPERIMENTAL

Treatment 1

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Treatment 2

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

Treatment 2

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Treatment 2

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

a placebo supplement that is similar in appearance to treatment 1

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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USANA Health Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Central Contacts

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Mark Levy, PhD

Role: CONTACT

(801) 954-7783

Rolando Maddela, MPH

Role: CONTACT

(801) 954-7568

Other Identifiers

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202401CT

Identifier Type: -

Identifier Source: org_study_id

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