Cardiovascular DiseasesNCT06245382
The Impact of Goode Health Beverage on Markers of Physiological and Neurocognitive Health
A study testing Goode Health Beverage and Vanilla Base Beverage Blend in people with Cardiovascular Diseases and Hypertension, run by The University of Texas at Arlington at 2 sites in United States.
Trial summary
The overall research objective of this proposal is to determine the acute and chronic impact of daily supplementation of a Good Health beverage on indices of physiological and neurocognitive health. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Cognitive Decline
- What is being tested?
- Goode Health Beverage and Vanilla Base Beverage Blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2023to 31 Dec 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women who are between the ages of 18-55
Who cannot join
- Individuals who have donated more than 550 ml of blood within the past 8 weeks will not have blood drawn from them in this protocol. However, if they remain interested in the study, and otherwise meet the inclusion criteria, then we may still opt to proceed with data collection.
- Any food allergy.
- Pregnant women
- Breast feeding
- Allergies to spandex/lycra.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UT Arlington - Science and Engineering Innovation and Research Building
Arlington, Texas, 76019
UT Arlington
Arlington, Texas, 76019
About this study
Official title: The Impact of Goode Health Beverage on Markers of Physiological and Neurocognitive
The overall research objective of this proposal is to determine the acute and chronic impact of daily supplementation of a Good Health beverage on indices of physiological and neurocognitive health.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality and affects all individuals. There are many primary risk factors for CVD with some of the primary causes including hypertension, hypercholesteremia, atherosclerosis, and type 2 diabetes mellitus. Furthermore, the rise in the prevalence of various neurocognitive conditions and cerebral vascular diseases including cognitive dysfunction, dementia, stroke, and Alzheimer's disease requires additional attention from a research perspective. While the reasons contributing to CVD and neurocognitive complications/cerebral vascular diseases, is multifactorial, a common link is impaired vascular function.
A hallmark of impaired vascular function is elevated arterial stiffness and a decrease in the vasodilator capacity in the brain and periphery. Reduced nitric oxide (NO) bioavailability, due to elevated oxidative stress and systemic inflammation is implicated as a primary contributing factor for these attenuated vasodilatory responses. Therefore, it is reasonable to speculate that an approach targeting these pathways could abolish or minimize this elevated risk. One such approach could be increased dietary consumption of a naturally based product that is high in polyphenol content and ingredients that are well-known to have beneficial effects on oxidative stress, inflammation, blood lipids etc. In turn this would be expected to have beneficial outcomes on various biomarkers associated with peripheral and cerebral vascular health including, cholesterol, lipid profile, insulin sensitivity/type II diabetes, cognitive health, arterial stiffness, blood pressure, and NO bioavailability and subsequently vascular function/health. Specifically, the Goode Health Super Food Smoothie Blend is a product that we are interested in investigating in this proposal.
- Primary Aim - The primary endpoint is the effect of increased daily consumption of the Good Health beverage on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. These outcomes include cognitive function, central and peripheral arterial blood pressure, cerebral and peripheral blood vessel function/health, and blood biomarkers (e.g., indices of inflammation, oxidative stress, insulin resistance/diabetes risk, and lipid profile).
- Secondary Aim - A secondary endpoint is the effect of daily consumption of the Good Health beverage on the following variables: waist circumference, body weight, and body mass index (BMI).
- Being tested
- Goode Health Beverage, Vanilla Base Beverage Blend
- Keywords
- endothelial function, brain blood flow, cognition
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goode Health BeverageDietary supplement
This is a commercially available beverage powder that is high is healthy ingredients that are believed to be beneficial for physiological health.
Vanilla Base Beverage BlendDietary supplement
This is a commercially available beverage powder.
| Study group | Role | What they receive |
|---|---|---|
| Goode Health Beverage | Experimental | Goode Health Beverage that is high in natural ingredients that are high in Polyphenol 3 content and also have anti-inflammatory and antioxidant properties Receives: Dietary Supplement: Goode Health Beverage |
| Vanilla Base Blend Beverage | Placebo comparator | The control beverage is similar but it does not contain the same amount of fiber, anti-inflammatory, and/or antioxidant properties (i.e. mainly smaller or no amounts of flax, ginger, cinnamon, turmeric, berberine bergamot, bilberry, black garlic, and green tea). Receives: Dietary Supplement: Vanilla Base Beverage Blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Flow medicated dilation of the brachial artery
Measured: baseline & following 2 weeks of daily beverage consumption
Neurocognitive Function
Performance on the NIH Toolbox Cognitive battery
Measured: baseline & following 2 weeks of daily beverage consumption
Peripheral blood pressure (systolic, diastolic, mean)
standard blood pressure measures
Measured: baseline & following 2 weeks of daily beverage consumption
Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG)
assessment of lipid profile
Measured: baseline & following 2 weeks of daily beverage consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Oct 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Individuals will be randomly assigned to either an experimental or a control condition.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Arlington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Brothers, The University of Texas at Arlington
- Investigators
- Robert M Brothers, PhD, Principal investigator, University of Texas at Arlington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245382
- Sponsor's protocol ID
- 2023-0202
- Status last verified
- Mar 2025
- First submitted
- 29 Jan 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IDP.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Goode Health Beverage on Markers of Physiological and Neurocognitive
- ClinicalTrials.gov ID
- NCT06245382
- Acronym / sponsor ID
- 2023-0202
- Keywords
- endothelial function, brain blood flow, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 7 Feb 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.
The overall research objective of this proposal is to determine the acute and chronic impact of daily supplementation of a Good Health beverage on indices of physiological and neurocognitive health.
Detailed description
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality and affects all individuals. There are many primary risk factors for CVD with some of the primary causes including hypertension, hypercholesteremia, atherosclerosis, and type 2 diabetes mellitus. Furthermore, the rise in the prevalence of various neurocognitive conditions and cerebral vascular diseases including cognitive dysfunction, dementia, stroke, and Alzheimer's disease requires additional attention from a research perspective. While the reasons contributing to CVD and neurocognitive complications/cerebral vascular diseases, is multifactorial, a common link is impaired vascular function.
A hallmark of impaired vascular function is elevated arterial stiffness and a decrease in the vasodilator capacity in the brain and periphery. Reduced nitric oxide (NO) bioavailability, due to elevated oxidative stress and systemic inflammation is implicated as a primary contributing factor for these attenuated vasodilatory responses. Therefore, it is reasonable to speculate that an approach targeting these pathways could abolish or minimize this elevated risk. One such approach could be increased dietary consumption of a naturally based product that is high in polyphenol content and ingredients that are well-known to have beneficial effects on oxidative stress, inflammation, blood lipids etc. In turn this would be expected to have beneficial outcomes on various biomarkers associated with peripheral and cerebral vascular health including, cholesterol, lipid profile, insulin sensitivity/type II diabetes, cognitive health, arterial stiffness, blood pressure, and NO bioavailability and subsequently vascular function/health. Specifically, the Goode Health Super Food Smoothie Blend is a product that we are interested in investigating in this proposal.
- Primary Aim - The primary endpoint is the effect of increased daily consumption of the Good Health beverage on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. These outcomes include cognitive function, central and peripheral arterial blood pressure, cerebral and peripheral blood vessel function/health, and blood biomarkers (e.g., indices of inflammation, oxidative stress, insulin resistance/diabetes risk, and lipid profile).
- Secondary Aim - A secondary endpoint is the effect of daily consumption of the Good Health beverage on the following variables: waist circumference, body weight, and body mass index (BMI).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Individuals will be randomly assigned to either an experimental or a control condition.
| Arm | Type | Receives |
|---|---|---|
| Goode Health Beverage | Experimental | Dietary Supplement: Goode Health BeverageGoode Health Beverage that is high in natural ingredients that are high in Polyphenol 3 content and also have anti-inflammatory and antioxidant properties |
| Vanilla Base Blend Beverage | Placebo comparator | Dietary Supplement: Vanilla Base Beverage BlendThe control beverage is similar but it does not contain the same amount of fiber, anti-inflammatory, and/or antioxidant properties (i.e. mainly smaller or no amounts of flax, ginger, cinnamon, turmeric, berberine bergamot, bilberry, black garlic, and green tea). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women who are between the ages of 18-55
Key exclusion criteria (5 listed)
- Individuals who have donated more than 550 ml of blood within the past 8 weeks will not have blood drawn from them in this protocol. However, if they remain interested in the study, and otherwise meet the inclusion criteria, then we may still opt to proceed with data collection.
- Any food allergy.
- Pregnant women
- Breast feeding
- Allergies to spandex/lycra.
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 |
|---|---|---|
| Goode Health BeverageThis is a commercially available beverage powder that is high is healthy ingredients that are believed to be beneficial for physiological health. | Dietary supplement | Goode Health Beverage |
| Vanilla Base Beverage BlendThis is a commercially available beverage powder. | Dietary supplement | Vanilla Base Blend Beverage |
Primary outcome
Endothelial Function
Time frame: baseline & following 2 weeks of daily beverage consumption
Flow medicated dilation of the brachial artery
Neurocognitive Function
Time frame: baseline & following 2 weeks of daily beverage consumption
Performance on the NIH Toolbox Cognitive battery
Peripheral blood pressure (systolic, diastolic, mean)
Time frame: baseline & following 2 weeks of daily beverage consumption
standard blood pressure measures
Lipid profile (Total-C, LDL-C, VLDL-C, HDL-C, TG)
Time frame: baseline & following 2 weeks of daily beverage consumption
assessment of lipid profile
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No. There is no plan to share IDP.
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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.
Robert M Brothers, PhD principal investigator
University of Texas at Arlington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goode Health Beverage and Vanilla Base Beverage Blend in people with Cardiovascular Diseases and Hypertension, run by The University of Texas at Arlington at 2 sites 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function (time frame: baseline & following 2 weeks of daily beverage consumption). The study lists 4 primary outcomes in all. 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 1 Apr 2025.