Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XO Genius | Dietary Supplement | This is a beverage powder that is high in healthy ingredients that are believed to be beneficial for physiological health |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Function | Flow medicated dilation of the brachial artery (% change) | 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 | 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) | 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 | 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 | 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) | 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) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert M Brothers, PhD | University of Texas at Arlington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Arlington - Science and Engineering Innovation and Research Building | Arlington | Texas | 76019 | United States |
There is not a plan to share IPD data
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D006973 | Hypertension |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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) | 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) | 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) | 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) | baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption |