XO Genius Beverage for Cognitive and Physiological Health

Overseen by Robert M Brothers, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The University of Texas at Arlington

Must not be taking: Cardiovascular, Metabolic, Stimulants

Disqualifiers: Food allergies, Diabetes, IBS, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

If you are currently taking medications for cardiovascular or metabolic conditions, or using prescription stimulants, you will not be eligible to participate in this trial.

What data supports the effectiveness of the treatment XO Genius Beverage for Cognitive and Physiological Health?

Research on ketone supplementation, a component of XO Genius, shows it can improve some cognitive functions during exercise and enhance memory in young adults. Additionally, ketogenic nutrition drinks have been shown to improve blood lipid profiles and maintain lean body mass in obese adults. ^{1 2 3 4 5}

Is XO Genius Beverage safe for human consumption?

Research on similar exogenous ketone drinks shows they are generally safe for humans, with mild and infrequent gastrointestinal effects. Studies found no significant changes in vital signs or lab tests, supporting their overall safety. ^{6 7 8 9 10}

How is the XO Genius Beverage treatment different from other treatments for cognitive and physiological health?

XO Genius Beverage is unique because it uses a ketone monoester to elevate blood ketone levels, which can improve cognitive and physical performance without the need for a strict ketogenic diet. This approach is simpler and more convenient compared to traditional methods of achieving ketosis, like dietary changes. ^{4 7 9 10 11}

Research Team

Robert M Brothers, PhD

Principal Investigator

University of Texas at Arlington

Eligibility Criteria

This trial is for individuals who may be at risk for heart disease, cognitive issues, or high blood pressure. Participants should be interested in healthy eating and looking to improve their waist size, weight, and BMI.

Inclusion Criteria

I am between 18 and 50 years old.

Exclusion Criteria

Breast feeding women

Food allergies

Pregnant women

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume the Keto5 XOGenius beverage daily to assess its impact on neurocognitive and physiological health

4 weeks

Baseline, 2 weeks, and 4 weeks visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• XO Genius (Dietary Supplement)

Trial Overview The study is testing the effects of a beverage called Keto5 XOGenius on health markers related to cardiovascular and neurocognitive conditions. It will measure changes in waist circumference, body weight, and BMI with daily consumption.

Participant Groups

Group I: Keto5 XOGenius Beverage Experimental Treatment 1 Intervention

Keto5 XOGenius Beverage contains natural ingredients that are high in the Ketone β-OHB content and has anti-inflammatory and antioxidant properties

Who Is Running the Clinical Trial?

The University of Texas at Arlington

Lead Sponsor

Trials

48

Recruited

7,300+

Findings from Research

Ingesting a ketone monoester (KME) with carbohydrates (CHO) increased blood levels of β-hydroxybutyrate and decreased glucose and lactate during exercise, indicating a shift in energy metabolism.

While the KME + CHO combination did not improve cycling performance times in a 10-km time trial, it significantly enhanced cognitive performance, leading to faster reaction times and improved task accuracy in trained females.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Ketone Monoester with Carbohydrate Improves Cognitive Measures Post-Exercise, but not Performance in Trained Females. Waldman, HS., O'Neal, EK., Barker, GA., et al.[2023]

A 6-week ketogenic diet (KD) in 42 healthy adults led to a significant weight loss of 2.0 kg, with good compliance indicated by 97% of days showing urinary ketosis, but resulted in a slight decrease in physical performance, including a 2.4% drop in VO2peak and a 4.1% decrease in peak power.

While the KD did not negatively affect daily activities, it raised concerns for competitive athletes due to the observed decline in endurance capacity, despite improvements in handgrip strength and significant reductions in glucose and insulin levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a 6-week non-energy-restricted ketogenic diet on physical fitness, body composition and biochemical parameters in healthy adults. Urbain, P., Strom, L., Morawski, L., et al.[2022]

In a study involving nine recreationally active men, ketone monoester (KME) supplementation was found to reduce cognitive fatigue during a simulated soccer match, leading to a smaller decrease in cognitive performance compared to a placebo.

KME also lowered blood glucose and lactate levels during exercise, suggesting it may help spare carbohydrates, which could be beneficial for athletes during high-intensity activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketone Ester Supplementation Improves Some Aspects of Cognitive Function during a Simulated Soccer Match after Induced Mental Fatigue. Quinones, MD., Lemon, PWR.[2023]

In a study of obese adults consuming low-calorie ketogenic drinks for two weeks, both the 4:1 and 1.7:1 ketogenic ratios effectively maintained elevated blood ketone levels, indicating successful ketosis induction.

All groups experienced significant weight and body fat loss, while the ketogenic drink groups also showed improved blood lipid profiles and reduced appetite, suggesting potential for ketogenic nutrition in obesity treatment and other health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-Week Exclusive Supplementation of Modified Ketogenic Nutrition Drink Reserves Lean Body Mass and Improves Blood Lipid Profile in Obese Adults: A Randomized Clinical Trial. Choi, HR., Kim, J., Lim, H., et al.[2023]

In a 28-day study involving 59 healthy adults, the novel exogenous ketone diester bis-hexanoyl-(R)-1,3-butanediol (BH-BD) was found to be well-tolerated and safe, with no significant differences in tolerability scores compared to a placebo.

BH-BD effectively increased blood ketone levels one hour after consumption, indicating its potential for promoting nutritional ketosis without adverse effects on vital signs or laboratory measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults. Chen, O., Blonquist, TM., Mah, E., et al.[2021]

Exogenous ketone drinks, such as ketone esters and ketone salts, effectively raise blood D-β-hydroxybutyrate (D-βHB) levels, with significant increases observed in a study of 15 participants, indicating a practical alternative to traditional ketogenic diets.

Both types of ketone drinks lowered blood glucose and triglyceride levels without causing adverse effects on blood electrolytes, suggesting they are safe and beneficial for metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On the Metabolism of Exogenous Ketones in Humans. Stubbs, BJ., Cox, PJ., Evans, RD., et al.[2022]

In a study involving 15 endurance-trained male athletes, carbohydrate electrolyte solutions (CES) with low doses of caffeine improved long-term memory before exercise compared to placebo drinks.

After exercise, CES drinks with low and medium doses of caffeine enhanced cognitive functions such as attention, psychomotor skills, and memory, demonstrating that even small amounts of caffeine can positively affect cognitive performance following strenuous physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caffeine improves cognitive performance after strenuous physical exercise. Hogervorst, E., Riedel, WJ., Kovacs, E., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Ketone Monoester with Carbohydrate Improves Cognitive Measures Post-Exercise, but not Performance in Trained Females. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Impact of a 6-week non-energy-restricted ketogenic diet on physical fitness, body composition and biochemical parameters in healthy adults. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of the Red Bull energy drink on cognitive function and mood in healthy young volunteers. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Ketone Ester Supplementation Improves Some Aspects of Cognitive Function during a Simulated Soccer Match after Induced Mental Fatigue. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Two-Week Exclusive Supplementation of Modified Ketogenic Nutrition Drink Reserves Lean Body Mass and Improves Blood Lipid Profile in Obese Adults: A Randomized Clinical Trial. [2023]

6. Venezuela pubmed.ncbi.nlm.nih.gov

[Development and optimization of an isotonic sports drink]. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Gastrointestinal Effects of Exogenous Ketone Drinks are Infrequent, Mild, and Vary According to Ketone Compound and Dose. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

On the Metabolism of Exogenous Ketones in Humans. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Caffeine improves cognitive performance after strenuous physical exercise. [2022]