Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318390
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-03-12
Brief Title:
The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health
Sponsor:
The University of Texas at Arlington
Organization:
The University of Texas at Arlington
Study Overview
Official Title:
The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 conditionsdiseases 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 Alzheimers disease requires additional attention from a research perspective While the reasons contributing to CVD and neurocognitive complicationscerebral 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 ie 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 objectivesaims will be explored
1 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 conditionsdiseases These outcomes include cognitive function central and peripheral arterial blood pressure cerebral and peripheral blood vessel functionhealth and blood biomarkers eg indices of inflammation oxidative stress insulin resistancediabetes risk and lipid profile
2 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
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 ie 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 objectivesaims will be explored
1 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 conditionsdiseases These outcomes include cognitive function central and peripheral arterial blood pressure cerebral and peripheral blood vessel functionhealth and blood biomarkers eg indices of inflammation oxidative stress insulin resistancediabetes risk and lipid profile
2 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None