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

NCT06442293 | Not Yet Recruiting

• 1 other identifier: 202401CT
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Safety Issues; Tolerance

Outcome Measures

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.

  4 weeks

Secondary Outcomes (2)

• Blood pressure assessment

  4 weeks

• Heart rate monitoring

  4 weeks

Study Arms (6)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Circulatory Beverage - low dose

EXPERIMENTAL

A beverage containing natural ingredients at a low dose

Dietary Supplement: Treatment 1

Circulatory Beverage - medium dose

EXPERIMENTAL

A beverage containing natural ingredients at a medium dose

Dietary Supplement: Treatment 1

Circulatory Beverage - high dose

EXPERIMENTAL

A beverage containing natural ingredients at a high dose

Dietary Supplement: Treatment 1

TCM Beverage - low dose

EXPERIMENTAL

A traditional Chinese medicine-based beverage containing natural ingredients at a low dose

Dietary Supplement: Treatment 2

TCM Beverage - high dose

EXPERIMENTAL

A traditional Chinese medicine-based beverage containing natural ingredients at a high dose

Dietary Supplement: Treatment 2

Interventions

Treatment 1 DIETARY_SUPPLEMENT

A dietary supplement containing beet root extract, arginine and citrulline

Circulatory Beverage - high dose; Circulatory Beverage - low dose; Circulatory Beverage - medium dose

Treatment 2 DIETARY_SUPPLEMENT

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

TCM Beverage - high dose; TCM Beverage - low dose

Placebo DIETARY_SUPPLEMENT

a placebo supplement that is similar in appearance to treatment 1

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• USANA Health Sciences: lead

Study Sites (1)

USANA Health Sciences

Salt Lake City, Utah, 84120, United States

Location

Study Officials

• Mark Levy, PhD

  USANA Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Levy, PhD

CONTACT

(801) 954-7783; mark.levy@usanainc.com

Rolando Maddela, MPH

CONTACT

(801) 954-7568; rolando.maddela@usanainc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single blind, placebo controlled

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: June 4, 2024
• Study Start: July 1, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)