NCT06318390

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

1.8 years

First QC Date

March 12, 2024

Last Update Submit

September 22, 2025

Conditions

Keywords

endothelial functionbrain blood flowcognition

Outcome Measures

Primary Outcomes (11)

  • 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)

    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

Study Arms (1)

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

Dietary Supplement: XO Genius

Interventions

XO GeniusDIETARY_SUPPLEMENT

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

Keto5 XOGenius Beverage

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Arlington - Science and Engineering Innovation and Research Building

Arlington, Texas, 76019, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionCognitive Dysfunction

Condition Hierarchy (Ancestors)

Vascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Robert M Brothers, PhD

    University of Texas at Arlington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2024

First Posted

March 19, 2024

Study Start

August 1, 2023

Primary Completion

May 15, 2025

Study Completion

May 31, 2025

Last Updated

September 26, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

There is not a plan to share IPD data

Locations