Safety IssuesNCT06442293
Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Healthy Blood Pressure.
A study testing Treatment 1 and Treatment 2 in people with Safety Issues and Tolerance, run by USANA Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Tolerance
- What is being tested?
- Treatment 1 and Treatment 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Safety Issues, Tolerance
- Being tested
- Treatment 1, Treatment 2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment 1Dietary supplement
A dietary supplement containing beet root extract, arginine and citrulline
Treatment 2Dietary supplement
A traditional Chinese medicine (TCM)-based dietary supplement containing chrysanthemum extract and eucommia bark extract
PlaceboDietary supplement
a placebo supplement that is similar in appearance to treatment 1
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | a placebo (microcrystalline cellulose) identical in size, shape and color to the treatment Receives: Dietary Supplement: Placebo |
| Circulatory Beverage - low dose | Experimental | A beverage containing natural ingredients at a low dose Receives: Dietary Supplement: Treatment 1 |
| Circulatory Beverage - medium dose | Experimental | A beverage containing natural ingredients at a medium dose Receives: Dietary Supplement: Treatment 1 |
| Circulatory Beverage - high dose | Experimental | A beverage containing natural ingredients at a high dose Receives: Dietary Supplement: Treatment 1 |
| TCM Beverage - low dose | Experimental | A traditional Chinese medicine-based beverage containing natural ingredients at a low dose Receives: Dietary Supplement: Treatment 2 |
| TCM Beverage - high dose | Experimental | A traditional Chinese medicine-based beverage containing natural ingredients at a high dose Receives: Dietary Supplement: Treatment 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (2)
Blood pressure assessment
An assessment of subjects' blood pressure throughout the 4-week study period.
Measured: 4 weeks
Heart rate monitoring
An assessment of subjects' heart rate throughout the 4-week study period.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jul 2024 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single blind, placebo controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USANA Health Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Levy, PhD, Principal investigator, USANA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442293
- Sponsor's protocol ID
- 202401CT
- Status last verified
- Jun 2024
- First submitted
- 23 Apr 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Safety and Tolerability of 2 Dietary Supplement Beverages Designed to Maintain Normal Blood Pressure in Normal, Healthy Individuals.
- ClinicalTrials.gov ID
- NCT06442293
- Acronym / sponsor ID
- 202401CT
- Conditions
- Safety Issues, Tolerance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- USANA Health SciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Aug 2024 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
- Model description
- single blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placeboa placebo (microcrystalline cellulose) identical in size, shape and color to the treatment |
| Circulatory Beverage - low dose | Experimental | Dietary Supplement: Treatment 1A beverage containing natural ingredients at a low dose |
| Circulatory Beverage - medium dose | Experimental | Dietary Supplement: Treatment 1A beverage containing natural ingredients at a medium dose |
| Circulatory Beverage - high dose | Experimental | Dietary Supplement: Treatment 1A beverage containing natural ingredients at a high dose |
| TCM Beverage - low dose | Experimental | Dietary Supplement: Treatment 2A traditional Chinese medicine-based beverage containing natural ingredients at a low dose |
| TCM Beverage - high dose | Experimental | Dietary Supplement: Treatment 2A traditional Chinese medicine-based beverage containing natural ingredients at a high dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment 1A dietary supplement containing beet root extract, arginine and citrulline | Dietary supplement | Circulatory Beverage - high dose, Circulatory Beverage - low dose, Circulatory Beverage - medium dose |
| Treatment 2A traditional Chinese medicine (TCM)-based dietary supplement containing chrysanthemum extract and eucommia bark extract | Dietary supplement | TCM Beverage - high dose, TCM Beverage - low dose |
| Placeboa placebo supplement that is similar in appearance to treatment 1 | Dietary supplement | Placebo |
Primary outcome
Aggregate Adverse Symptom Score
Time frame: 4 weeks
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.
2 secondary outcomes
Blood pressure assessment
Time frame: 4 weeks
Heart rate monitoring
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Safety Issues
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
Not yet recruitingPhase 1
Phase 1 Study to Evaluate RG002C0106 Injection in Healthy Participants
Safety Issues
Enrolling by invitation
Pediatric Trauma Centers RE-AIM at Gun Safety
Firearm Injury, Safety Issues
RecruitingObservational study
Efficacy and Safety of a New Sperm Capacitation Method
Reproductive Issues, Male Infertility
Active, not recruitingPhase 1/2
Role of a CCK Receptor Antagonist Proglumide in Management of Chronic Pancreatitis
Safety Issues, Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Levy, PhD principal investigator
USANA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment 1 and Treatment 2 in people with Safety Issues and Tolerance, run by USANA Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Levy, PhD ((801) 954-7783, mark.levy@usanainc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aggregate Adverse Symptom Score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.