XO Genius Beverage for Cognitive and Physiological Health
Recruiting in Palo Alto (17 mi)
Overseen byRobert 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?
Is XO Genius Beverage safe for human consumption?
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.4791011
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
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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 OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Keto5 XOGenius BeverageExperimental Treatment1 Intervention
Keto5 XOGenius Beverage contains natural ingredients that are high in the Ketone β-OHB content and has anti-inflammatory and antioxidant properties
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UT Arlington - Science and Engineering Innovation and Research BuildingArlington, TX
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Who Is Running the Clinical Trial?
The University of Texas at ArlingtonLead Sponsor
References
A Ketone Monoester with Carbohydrate Improves Cognitive Measures Post-Exercise, but not Performance in Trained Females. [2023]Acute ingestion of a ketone monoester with co-ingestion of a carbohydrate (KME + CHO) compared to carbohydrate (CHO) was investigated on cycling performance and cognitive performance in trained females.
Impact of a 6-week non-energy-restricted ketogenic diet on physical fitness, body composition and biochemical parameters in healthy adults. [2022]The ketogenic diet (KD) is a very low-carbohydrate, high-fat and adequate-protein diet that without limiting calories induces different metabolic adaptations, eg, increased levels of circulating ketone bodies and a shift to lipid metabolism. Our objective was to assess the impact of a 6-week non-energy-restricted KD in healthy adults beyond cohorts of athletes on physical performance, body composition, and blood parameters.
Effects of the Red Bull energy drink on cognitive function and mood in healthy young volunteers. [2018]The present study compared the cognitive and mood effects of two commercially available products, Red Bull energy drink 250 mL and Red Bull Sugarfree energy drink 250 mL, together with a matching placebo 250 mL. Twenty-four healthy young volunteers took part in a randomised, placebo controlled, double-blind, three-way cross-over study. Cognitive function was assessed using an integrated set of nine computerised tests of attention, working and episodic memory. On each study day the volunteers received a standardised breakfast prior to completing a baseline performance on cognitive tests and mood scales, followed by the consumption of the study drink. The cognitive tests and scales were then re-administered at 30, 60 and 90 min post-dose. Red Bull was found to produce significant improvements over both the Sugarfree version and the placebo drink on two composite scores from the six working and episodic memory tests; one combining the 12 accuracy measures from the six tasks and the other the average speed of correct responses from the working memory and episodic recognition memory tasks. These improvements were in the range of a medium effect size, which reflects a substantial enhancement to memory in young volunteers.
Ketone Ester Supplementation Improves Some Aspects of Cognitive Function during a Simulated Soccer Match after Induced Mental Fatigue. [2023]Ketone supplementation has been proposed to enhance cognition during exercise. To assess whether any benefits are due to reduced cognitive fatigue during the latter portions of typical sport game action, we induced cognitive fatigue, provided a ketone monoester supplement (KME) vs. a non-caloric placebo (PLAC), and assessed cognitive performance during a simulated soccer match (SSM). In a double-blind, balanced, crossover design, nine recreationally active men (174.3 ± 4.2 cm, 76.6 ± 7.4 kg, 30 ± 3 y, 14.2 ± 5.5 % body fat, V˙O2 max = 55 ± 5 mL·kg BM−1·min−1; mean ± SD) completed a 45-min SSM (3 blocks of intermittent, variable intensity exercise) consuming either KME (25 g) or PLAC, after a 40-min mental fatiguing task. Cognitive function (Stroop and Choice Reaction Task [CRT]) and blood metabolites were measured throughout the match. KME reduced concentrations of both blood glucose (block 2: 4.6 vs. 5.2 mM, p = 0.02; block 3: 4.7 vs. 5.3 mM, p = 0.01) and blood lactate (block 1: 4.7 vs. 5.4 mM, p = 0.05; block 2: 4.9 vs. 5.9 mM, p = 0.01) during the SSM vs. PLAC, perhaps indicating a CHO sparing effect. Both treatments resulted in impaired CRT performance during the SSM relative to baseline, but KME displayed a reduced (p
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]The ketogenic diet has long been recommended in patients with neurological disorders, and its protective effects on the cardiovascular system are of growing research interest. This study aimed to investigate the effects of two-week of low-calorie ketogenic nutrition drinks in obese adults. Subjects were randomized to consume drinks either a ketone-to-non-ketone ratio of 4:1 (KD 4:1), a drink partially complemented with protein at 1.7:1 (KD 1.7:1), or a balanced nutrition drink (BD). Changes in body weight, body composition, blood lipid profile, and blood ketone bodies were investigated. Blood ketone bodies were induced and maintained in the group that consumed both 4:1 and 1.7:1 ketogenic drinks (p < 0.001). Body weight and body fat mass significantly declined in all groups between 0 and 1 week and between 1 and 2 weeks (p < 0.05), while skeletal muscle mass remained unchanged only in the KD 1.7:1 group (p > 0.05). The blood lipid profile improved, appetite was reduced, and fullness was maintained in the two ketogenic drink groups. This study indicates the possibility for the development of obesity treatments based on ketogenic nutrition drinks even with a moderate ketogenic ratio of 1.7:1, as well as adjuvant therapies based on ketosis induction and maintenance for the treatment of other diseases and health conditions.
[Development and optimization of an isotonic sports drink]. [2016]Within a research program on food products for athletes starting from natural apple concentrate, the design, manufacture and control of isotonic beverages, was undertaken. The dilution conditions for the apple concentrate were established studying several salts combinations which will supply those electrolytes that are eliminated through sweat and have to be replenished. They are sodium, potassium, chloride, magnesium and calcium in concentrations such as to supply an osmotic pressure similar to that observed in blood. The addition of a premix of vitamins (B1, B2, B6, B12, C, E, folic acid, niacin, pantothenic acid and biotin) in several levels of the Recommended Daily Allowance (RDA) (100, 75, 62.5, 60 and 30% of the RDA) was assayed. The obtained formula tasted salty and medicine-like, therefore the vitamin content had to be reduced, supplying 30% of the RDA in a premix constituted by those vitamins which are the most important for physical activity (B1, B2, B6 and C). The quality of the formula was optimized considering variables such as flavor, color and maltodextrin levels by using methods of sensory evaluation. In the elaborated beverage controls such as pH, acidity, total solids (degree Bx), relative density and soluble solids/acidity ratio complying with the corresponding standards, were carried out. In addition, chemical composition, caloric value, microbiological and sensory quality, were controlled. The fruit juice was packed in a 250 ml self-supporting"Doy-Pack"-like bag. Both, microbiological and sensory quality were good, and the caloric value was 101.18 Kcal/250ml. Shelf life studies at two different temperature conditions 15-25 degrees C and 3-5 degrees C, were carried out. The limiting factor was flavor which defined a shelf life of at least 3 months, stored at refrigeration temperature (3-5 degrees C). The formulated beverage supply the electrolyte concentrations which allows to be characterized as isotonic beverage, recommended for athletes.
Gastrointestinal Effects of Exogenous Ketone Drinks are Infrequent, Mild, and Vary According to Ketone Compound and Dose. [2021]Exogenous ketone drinks may improve athletic performance and recovery, but information on their gastrointestinal tolerability is limited. Studies to date have used a simplistic reporting methodology that inadequately represents symptom type, frequency, and severity. Herein, gastrointestinal symptoms were recorded during three studies of exogenous ketone monoester (KME) and salt (KS) drinks. Study 1 compared low- and high-dose KME and KS drinks consumed at rest. Study 2 compared KME with isocaloric carbohydrate (CHO) consumed at rest either when fasted or after a standard meal. Study 3 compared KME+CHO with isocaloric CHO consumed before and during 3.25 hr of bicycle exercise. Participants reported symptom type and rated severity between 0 and 8 using a Likert scale at regular intervals. The number of visits with no symptoms reported after ketone drinks was n = 32/60 in Study 1, n = 9/32 in Study 2, and n = 20/42 in Study 3. Following KME and KS drinks, symptoms were acute but mild and were fully resolved by the end of the study. High-dose KS drinks caused greater total-visit symptom load than low-dose KS drinks (13.8 ± 4.3 vs. 2.0 ± 1.0; p
Tolerability and Safety of a Novel Ketogenic Ester, Bis-Hexanoyl (R)-1,3-Butanediol: A Randomized Controlled Trial in Healthy Adults. [2021]Nutritional ketosis is a state of mildly elevated blood ketone concentrations resulting from dietary changes (e.g., fasting or reduced carbohydrate intake) or exogenous ketone consumption. In this study, we determined the tolerability and safety of a novel exogenous ketone diester, bis-hexanoyl-(R)-1,3-butanediol (BH-BD), in a 28-day, randomized, double-blind, placebo-controlled, parallel trial (NCT04707989). Healthy adults (n = 59, mean (SD), age: 42.8 (13.4) y, body mass index: 27.8 (3.9) kg/m2) were randomized to consume a beverage containing 12.5 g (Days 0-7) and 25 g (Days 7-28) of BH-BD or a taste-matched placebo daily with breakfast. Tolerability, stimulation, and sedation were assessed daily by standardized questionnaires, and blood and urine samples were collected at Days 0, 7, 14, and 28 for safety assessment. There were no differences in at-home composite systemic and gastrointestinal tolerability scores between BH-BD and placebo at any time in the study, or in acute tolerability measured 1-h post-consumption in-clinic. Weekly at-home composite tolerability scores did not change when BH-BD servings were doubled. At-home scores for stimulation and sedation did not differ between groups. BH-BD significantly increased blood ketone concentrations 1-h post-consumption. No clinically meaningful changes in safety measures including vital signs and clinical laboratory measurements were detected within or between groups. These results support the overall tolerability and safety of consumption of up to 25 g/day BH-BD.
Kinetics, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate in healthy adult subjects. [2022]Induction of mild states of hyperketonemia may improve physical and cognitive performance. In this study, we determined the kinetic parameters, safety and tolerability of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone monoester administered in the form of a meal replacement drink to healthy human volunteers. Plasma levels of β-hydroxybutyrate and acetoacetate were elevated following administration of a single dose of the ketone monoester, whether at 140, 357, or 714 mg/kg body weight, while the intact ester was not detected. Maximum plasma levels of ketones were attained within 1-2h, reaching 3.30 mM and 1.19 mM for β-hydroxybutyrate and acetoacetate, respectively, at the highest dose tested. The elimination half-life ranged from 0.8-3.1h for β-hydroxybutyrate and 8-14 h for acetoacetate. The ketone monoester was also administered at 140, 357, and 714 mg/kg body weight, three times daily, over 5 days (equivalent to 0.42, 1.07, and 2.14 g/kg/d). The ketone ester was generally well-tolerated, although some gastrointestinal effects were reported, when large volumes of milk-based drink were consumed, at the highest ketone monoester dose. Together, these results suggest ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate is a safe and simple method to elevate blood ketone levels, compared with the inconvenience of preparing and consuming a ketogenic diet.
On the Metabolism of Exogenous Ketones in Humans. [2022]Background and aims: Currently there is considerable interest in ketone metabolism owing to recently reported benefits of ketosis for human health. Traditionally, ketosis has been achieved by following a high-fat, low-carbohydrate "ketogenic" diet, but adherence to such diets can be difficult. An alternative way to increase blood D-β-hydroxybutyrate (D-βHB) concentrations is ketone drinks, but the metabolic effects of exogenous ketones are relatively unknown. Here, healthy human volunteers took part in three randomized metabolic studies of drinks containing a ketone ester (KE); (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, or ketone salts (KS); sodium plus potassium βHB. Methods and Results: In the first study, 15 participants consumed KE or KS drinks that delivered ~12 or ~24 g of βHB. Both drinks elevated blood D-βHB concentrations (D-βHB Cmax: KE 2.8 mM, KS 1.0 mM, P < 0.001), which returned to baseline within 3-4 h. KS drinks were found to contain 50% of the L-βHB isoform, which remained elevated in blood for over 8 h, but was not detectable after 24 h. Urinary excretion of both D-βHB and L-βHB was <1.5% of the total βHB ingested and was in proportion to the blood AUC. D-βHB, but not L-βHB, was slowly converted to breath acetone. The KE drink decreased blood pH by 0.10 and the KS drink increased urinary pH from 5.7 to 8.5. In the second study, the effect of a meal before a KE drink on blood D-βHB concentrations was determined in 16 participants. Food lowered blood D-βHB Cmax by 33% (Fed 2.2 mM, Fasted 3.3 mM, P < 0.001), but did not alter acetoacetate or breath acetone concentrations. All ketone drinks lowered blood glucose, free fatty acid and triglyceride concentrations, and had similar effects on blood electrolytes, which remained normal. In the final study, participants were given KE over 9 h as three drinks (n = 12) or a continuous nasogastric infusion (n = 4) to maintain blood D-βHB concentrations greater than 1 mM. Both drinks and infusions gave identical D-βHB AUC of 1.3-1.4 moles.min. Conclusion: We conclude that exogenous ketone drinks are a practical, efficacious way to achieve ketosis.
Caffeine improves cognitive performance after strenuous physical exercise. [2022]The effects of three carbohydrate electrolyte solutions (CES) containing different amounts of caffeine on cognitive function and the combined effects of these drinks and exercise on cognitive functions were investigated in a double-blind, cross-over study. On five separate occasions, fifteen endurance trained male athletes (23.3 years) received water placebo, CES placebo (68.8 g/l), and three CES drinks containing low, medium and high dosages of caffeine (150, 225 and 320 mg/l). Each occasion, 8 ml/kg of the drink was consumed before -- and 6 ml/kg of the drink was consumed during an all-out 1 hour time trial on a bicycle ergometer. Cognitive (attentional, psychomotor, and memory) tests were carried out immediately before and immediately after exercise. Before exercise, long term memory was improved by CES plus low dose caffeine compared to both placebos. Immediately after exercise, all cognitive functions were improved by CES plus low- and medium-dose caffeine compared to placebo. These results comprise the first practical demonstration of the cognition improving effects of low amounts of caffeine in CES after strenuous physical exercise.