XO Genius Beverage for Cognitive and Physiological Health

Overseen By Alison Mancera, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Arlington

Must not be taking: Cardiovascular, Metabolic, Stimulants

Disqualifiers: Food allergies, Diabetes, IBS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the potential impact of the Keto5 XOGenius beverage on brain and body health. Researchers aim to determine if daily consumption of this beverage can reduce risks for certain brain-related and physical conditions, while also monitoring changes in waist size, body weight, and BMI (a measure of body fat based on height and weight). The beverage contains natural ingredients with anti-inflammatory and antioxidant properties. This trial suits individuals without food allergies or diabetes, who are not taking certain medications, and who do not have digestive issues. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on natural health solutions.

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.

Is there any evidence suggesting that the XO Genius beverage is likely to be safe for humans?

Research shows that the XO Genius drink, high in ketones, is generally safe. Studies on similar ketone drinks have found them to be well-tolerated. Most side effects, such as stomach issues, are mild and uncommon. One study found that this type of drink offers anti-inflammatory and antioxidant benefits, enhancing its safety profile. So far, no strong evidence of serious side effects has emerged, making it a potentially safe choice for those interested in trying it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

XO Genius is unique because it taps into the power of natural ingredients high in Ketone β-OHB, which may support brain and body health through its anti-inflammatory and antioxidant properties. Traditional treatments for cognitive and physiological health often focus on pharmaceuticals or supplements that can take time to show effects. Researchers are excited about XO Genius because its innovative approach targets inflammation and oxidation, potentially offering a more natural and faster-acting alternative to standard options.

What evidence suggests that the XO Genius beverage might be effective for cognitive and physiological health?

Research has shown that the Keto5 XOGenius drink, high in ketone β-OHB, might enhance brain function, particularly in individuals with mild memory issues. It raises blood ketone levels, which link to improved brain performance. The drink contains ingredients that reduce inflammation and act as antioxidants, benefiting both brain and body health. Early results suggest it might also aid in addressing weight-related issues such as waist size, body weight, and BMI, which are crucial for overall health. This makes it a promising option for improving both mental and physical health. ^{1 2 3 5 6}

Who Is on the Research Team?

Robert M Brothers, PhD

Principal Investigator

University of Texas at Arlington

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

Breast feeding women

Food allergies

Pregnant women

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• XO Genius

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Exogenous ketone drinks, both monoester and salt forms, can cause mild gastrointestinal symptoms, with symptom severity influenced by the dose and type of drink consumed, as well as whether the individual is at rest or exercising.

High-dose ketone salt drinks resulted in more gastrointestinal symptoms compared to low-dose versions, but overall, symptoms were acute and resolved by the end of the study, indicating that while they may cause discomfort, they are generally tolerable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal Effects of Exogenous Ketone Drinks are Infrequent, Mild, and Vary According to Ketone Compound and Dose. Stubbs, BJ., Cox, PJ., Kirk, T., et al.[2021]

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]

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 24 healthy young volunteers, the regular Red Bull energy drink significantly improved cognitive function, particularly in working and episodic memory, compared to both the Sugarfree version and a placebo.

The improvements in memory were substantial, with a medium effect size indicating that Red Bull can enhance cognitive performance in young individuals shortly after consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the Red Bull energy drink on cognitive function and mood in healthy young volunteers. Wesnes, KA., Brooker, H., Watson, AW., et al.[2018]

The developed isotonic beverage from natural apple concentrate effectively replenishes key electrolytes lost through sweat, such as sodium, potassium, and magnesium, making it suitable for athletes.

The beverage was optimized for taste and quality, achieving a shelf life of at least 3 months when stored at refrigeration temperatures, while providing 30% of the Recommended Daily Allowance of essential vitamins for physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development and optimization of an isotonic sports drink]. López, L., Wittig de Penna, E., Bunger, A., et al.[2016]

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]

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]

The ketone monoester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate effectively elevates blood ketone levels in healthy volunteers, reaching maximum plasma concentrations of 3.30 mM for β-hydroxybutyrate within 1-2 hours after ingestion.

This ketone monoester was generally well-tolerated over a 5-day period, although some gastrointestinal side effects were noted at higher doses, indicating it is a safe alternative to traditional ketogenic diets for enhancing physical and cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects. Clarke, K., Tchabanenko, K., Pawlosky, R., et al.[2022]

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]

Citations

1. withpower.com withpower.com/trial/phase-cardiovascular-diseases-7-2023-edb27

XO Genius Beverage for Cognitive and Physiological Health Trial Overview The study is testing the effects of a beverage called Keto5 XOGenius on health markers related to cardiovascular and neurocognitive conditions.

2. ctv.veeva.com ctv.veeva.com/study/the-impact-of-keto5-xogenius-beverage-on-markers-of-physiological-and-neurocognitive-health

The Impact of KETO5 XOGenius Beverage on Markers of ... The primary objectives of this application are to 1) investigate the effect of increased daily consumption of the Keto5 XOGenius beverage on outcomes ...

3. withpower.com withpower.com/clinical-trials/for-dementia?page=2

Top Dementia Clinical Trials | Power XO Genius Beverage for Cognitive and Physiological Health. Arlington, Texas. The primary objectives of this application are to 1) investigate the effect of ...

4. startengine.com startengine.com/offering/keto5

Keto5 (Reg CF) ... XOGenius + XO*) drink improved cognitive outcomes in mild cognitive impairment, at least in part by increasing blood ketone level. These ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06515717

NCT06515717 | Exogenous Ketones and Behavior This study investigates the effects of exogenous ketone ester on behavior, cognition, and metabolism over one week of consumption. Using a within-subjects, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8803132/

Efficacy and Safety of Ketone Supplementation or Ketogenic ... This review summarizes the available evidence regarding KS/KD as therapeutic options for individuals with AD.