Skip to main content
OpenTrials
Completed

NCT Number: NCT06318390

The Impact of KETO5 XOGenius Beverage on Markers of Physiological and Neurocognitive Health

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Diet Healthy Hypertension Mental Disorders Neurocognitive Disorders Vascular Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Arlington - Science and Engineering Innovation and Research Building

Arlington, Texas, 76019, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XO Genius

Dietary Supplement

This is a beverage powder that is high in healthy ingredients that are believed to be beneficial for physiological health

Primary outcomes

  1. 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)

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

Sponsors and collaborators

Lead sponsor

The University of Texas at Arlington

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 19, 2024
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.