Clinical trial NCT06318390: The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health
Official title: The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Hypertension
Cognitive Decline
Diet
Healthy
Keywords: endothelial function
brain blood flow
cognition
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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:

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 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).
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).

Eligibility criteria: Inclusion Criteria:

* Men and women who are between the ages of 18-50

Exclusion Criteria:

* 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
* Breast feeding women
* Allergy to spandex/lycra/latex
* Anemia
* Use of prescription stimulants

Primary outcomes:
measure: Endothelial Function
timeFrame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
measure: Neurocognitive Function
timeFrame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
measure: Peripheral systolic blood pressure
timeFrame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
measure: Plasma concentration of Total Cholesterol (Total-C)
timeFrame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
measure: Arterial stiffness
timeFrame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
measure: Peripheral diastolic blood pressure (diastolic)
timeFrame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
measure: Peripheral mean blood pressure (mean)
timeFrame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
measure: Plasma concentration of High Density Lipoprotein (HDL-C)
timeFrame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
measure: Plasma concentration of Low Density Lipoprotein (LDL-C)
timeFrame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
measure: Plasma concentration of Very Low Density Lipoprotein (VLDL-C)
timeFrame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
measure: Plasma concentration of Triglycerides (TG)
timeFrame: baseline, 2 weeks post daily consumption of Keto5 XOgenius, & 4 weeks of daily keto5 XOgenius consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Arlington
country: United States
facility: UT Arlington - Science and Engineering Innovation and Research Building
state: Texas
Study officials:
affiliation: University of Texas at Arlington
name: Robert M Brothers, PhD
role: PRINCIPAL_INVESTIGATOR
References: