Cardiovascular DiseasesNCT06318390
The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health
A study testing XO Genius in people with Cardiovascular Diseases and Hypertension, run by The University of Texas at Arlington at 1 site in United States.
Trial summary
The primary objectives of this application are to 1) investigate the effect of increased daily consumption of the Keto5 XOGenius beverage on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Cognitive Decline
- What is being tested?
- XO Genius
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 31 May 2025
- 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
- Men and women who are between the ages of 18-50
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.
- Food allergies
- Type I diabetes/Type II diabetes, and/or a history of hypoglycemia.
- History of irritable bowel syndrome or inflammatory bowel disease.
- Currently taking any medications that are designed to treat a cardiovascular or metabolic condition
- Pregnant women
Show all 10Show fewer
- Breast feeding women
- Allergy to spandex/lycra/latex
- Anemia
- Use of prescription stimulants
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Arlington - Science and Engineering Innovation and Research Building
Arlington, Texas, 76019
About this study
The primary objectives of this application are to 1) investigate the effect of increased daily consumption of the Keto5 XOGenius beverage on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. And 2) to investigate the effect of daily consumption of the Keto5 XOGenius beverage on the following variables: waist circumference, body weight, and body mass index (BMI).
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 vascular function, 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 the ketone β-hydroxybutyrate (β-OHB). Importantly, recent research has indicated that short-term dietary supplementation (i.e. up to 14 days) of β-OHB has many important physiological benefits including improvements in peripheral and cerebral vascular function as well as cognitive function. Furthermore, it has been demonstrated that these beneficial effects are due in part to reductions in systemic oxidative stress and inflammation. Furthermore, this approach of oral supplementation has been demonstrated to be safe and well tolerated in various populations. In this regard, the overall research objective of this proposal is to determine the acute and chronic impact of daily supplementation of a Keto5 XOGenius on indices of physiological and neurocognitive health. Specifically, the Keto5 XOGenius is the product that we are interested in investigating in this proposal
The following objectives/aims will be explored:
- Primary Aim - The primary endpoint is the effect of increased daily consumption of the Keto5 XOGenius 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 Keto5 XOGenius beverage on the following variables: waist circumference, body weight, and body mass index (BMI).
- Conditions
- Cardiovascular Diseases, Hypertension, Cognitive Decline, Diet, Healthy
- Being tested
- XO Genius
- 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.
XO GeniusDietary supplement
This is a beverage powder that is high in healthy ingredients that are believed to be beneficial for physiological health
| Study group | Role | What they receive |
|---|---|---|
| Keto5 XOGenius Beverage | Experimental | Keto5 XOGenius Beverage contains natural ingredients that are high in the Ketone β-OHB content and has anti-inflammatory and antioxidant properties Receives: Dietary Supplement: XO Genius |
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 (% change)
Measured: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Neurocognitive Function
Performance on the NIH Toolbox Cognitive battery
Measured: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Peripheral systolic blood pressure
standard blood pressure measures (mmHg)
Measured: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Plasma concentration of Total Cholesterol (Total-C)
assessment of Total Cholesterol
Measured: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Arterial stiffness
assessment of pulse wave velocity and pulse wave analysis
Measured: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Peripheral diastolic blood pressure (diastolic)
standard blood pressure measures (mmHg)
Measured: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Peripheral mean blood pressure (mean)
standard blood pressure measures (mmHg)
Measured: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Plasma concentration of High Density Lipoprotein (HDL-C)
assessment of High Density Lipoprotein (HDL-C)
Measured: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Plasma concentration of Low Density Lipoprotein (LDL-C)
assessment of Low Density Lipoprotein (LDL-C)
Measured: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Plasma concentration of Very Low Density Lipoprotein (VLDL-C)
assessment of Low Density Lipoprotein (VLDL-C)
Measured: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Plasma concentration of Triglycerides (TG)
assessment of Triglycerides (TG)
Measured: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Aug 2023
- Primary completion15 May 2025
- Study completion31 May 2025
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT06318390
- Sponsor's protocol ID
- 2023-0271
- Status last verified
- Sep 2025
- First submitted
- 12 Mar 2024
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to share IPD data
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health
- ClinicalTrials.gov ID
- NCT06318390
- Acronym / sponsor ID
- 2023-0271
- Conditions
- Cardiovascular Diseases, Hypertension, Cognitive Decline, Diet, Healthy
- Keywords
- endothelial function, brain blood flow, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The University of Texas at ArlingtonUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 19 Mar 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 primary objectives of this application are to 1) investigate the effect of increased daily consumption of the Keto5 XOGenius beverage on outcomes associated with elevated risk for various neurocognitive and pathophysiological conditions/diseases. And 2) to investigate the effect of daily consumption of the Keto5 XOGenius beverage on the following variables: waist circumference, body weight, and body mass index (BMI).
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 vascular function, 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 the ketone β-hydroxybutyrate (β-OHB). Importantly, recent research has indicated that short-term dietary supplementation (i.e. up to 14 days) of β-OHB has many important physiological benefits including improvements in peripheral and cerebral vascular function as well as cognitive function. Furthermore, it has been demonstrated that these beneficial effects are due in part to reductions in systemic oxidative stress and inflammation. Furthermore, this approach of oral supplementation has been demonstrated to be safe and well tolerated in various populations. In this regard, the overall research objective of this proposal is to determine the acute and chronic impact of daily supplementation of a Keto5 XOGenius on indices of physiological and neurocognitive health. Specifically, the Keto5 XOGenius is the product that we are interested in investigating in this proposal
The following objectives/aims will be explored:
- Primary Aim - The primary endpoint is the effect of increased daily consumption of the Keto5 XOGenius 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 Keto5 XOGenius beverage on the following variables: waist circumference, body weight, and body mass index (BMI).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Keto5 XOGenius Beverage | Experimental | Dietary Supplement: XO GeniusKeto5 XOGenius Beverage contains natural ingredients that are high in the Ketone β-OHB content and has anti-inflammatory and antioxidant properties |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men and women who are between the ages of 18-50
Key exclusion criteria (10 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.
- Food allergies
- Type I diabetes/Type II diabetes, and/or a history of hypoglycemia.
- History of irritable bowel syndrome or inflammatory bowel disease.
- Currently taking any medications that are designed to treat a cardiovascular or metabolic condition
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 |
|---|---|---|
| XO GeniusThis is a beverage powder that is high in healthy ingredients that are believed to be beneficial for physiological health | Dietary supplement | Keto5 XOGenius Beverage |
Primary outcome
Endothelial Function
Time frame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Flow medicated dilation of the brachial artery (% change)
Neurocognitive Function
Time frame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Performance on the NIH Toolbox Cognitive battery
Peripheral systolic blood pressure
Time frame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
standard blood pressure measures (mmHg)
Plasma concentration of Total Cholesterol (Total-C)
Time frame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
assessment of Total Cholesterol
Arterial stiffness
Time frame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
assessment of pulse wave velocity and pulse wave analysis
Peripheral diastolic blood pressure (diastolic)
Time frame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
standard blood pressure measures (mmHg)
Peripheral mean blood pressure (mean)
Time frame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
standard blood pressure measures (mmHg)
Plasma concentration of High Density Lipoprotein (HDL-C)
Time frame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
assessment of High Density Lipoprotein (HDL-C)
Plasma concentration of Low Density Lipoprotein (LDL-C)
Time frame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
assessment of Low Density Lipoprotein (LDL-C)
Plasma concentration of Very Low Density Lipoprotein (VLDL-C)
Time frame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
assessment of Low Density Lipoprotein (VLDL-C)
Plasma concentration of Triglycerides (TG)
Time frame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
assessment of Triglycerides (TG)
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 26 Sep 2025.
- Individual participant dataSharing planned: No. There is not a plan to share IPD data
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XO Genius in people with Cardiovascular Diseases and Hypertension, run by The University of Texas at Arlington 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 1 inclusion and 10 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 26 Sep 2025. 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. 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, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption). The study lists 11 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 26 Sep 2025.