45 Participants Needed

Ketone Monoester for Cognitive Function

Recruiting at 2 trial locations
SK
EP
Overseen ByEric Plaisance
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a supplement called ketone monoester to determine its effect on thinking and reaction skills. Researchers aim to discover if its effects vary among individuals who are obese and inactive, lean and inactive, or lean and very active, such as athletes. Suitable candidates for this trial include adults who either exercise infrequently and are obese or lean, or those who are athletes and exercise regularly. Participants will take the supplement and a placebo (a fake treatment) on different days to compare the effects on their thinking and reactions. As an unphased trial, this study provides a unique opportunity to understand how ketone monoester affects different lifestyles and body types.

Will I have to stop taking my current medications?

If you are taking medications for diabetes, mood disorders, or attention disorders, you will need to stop, as these are excluded from the trial.

Is there any evidence suggesting that ketone monoester supplementation is safe?

A previous study demonstrated that ketone monoester (KME) is safe and easy for people to use, inducing a strong state of ketosis, where the body uses fat for energy instead of sugar, without major side effects. Another study found no significant negative reactions in people who took KME, suggesting it is generally well-tolerated.

Overall, research indicates that KME is safe for human use, with no major reports of harmful effects. This suggests KME could be a safe option for those considering joining a trial involving this treatment.12345

Why are researchers excited about this trial?

Most treatments for cognitive decline typically focus on neurotransmitter balance or neuroprotection and often take weeks to show noticeable effects. However, ketone monoester (KME) is unique because it provides an alternative energy source for the brain, potentially enhancing cognitive function quickly. KME is metabolized into ketones, which can provide an immediate energy boost, possibly improving cognitive assessments in just a single dose. Researchers are excited about KME because it offers a novel mechanism of action compared to conventional approaches, potentially providing faster and more direct cognitive benefits.

What evidence suggests that ketone monoester might be an effective treatment for cognitive function?

Research has shown that ketone monoester (KME), which participants in this trial may receive, can improve brain function. One study found that people who took KME experienced a small but noticeable boost in mental abilities. Another study discovered that KME helped individuals think clearly in challenging situations, such as low-oxygen environments. KME is also safe and can induce a fat-burning state called ketosis without requiring a strict diet. However, in some cases, such as high-altitude activities, KME did not demonstrate clear benefits. Overall, early evidence suggests that KME can enhance brain function in certain situations.12345

Are You a Good Fit for This Trial?

This trial is for adults aged 19-55 who are either obese and sedentary, lean and sedentary, or lean with regular physical activity like athletes. Participants must be healthy otherwise and not taking any cognitive performance-affecting drugs.

Inclusion Criteria

Active athlete status (≥5 days/week of structured activity) for athlete group
Sedentary status (<2 hrs/week of structured physical activity) for obese and lean groups
My BMI is between 30-40 for obese, or 18-25 for lean/athlete.
See 1 more

Exclusion Criteria

Pregnant or breastfeeding
I am taking medication for diabetes, mood, or attention disorders.
I have a diagnosed neurological condition like Parkinson's or MS.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo two test days separated by 3-7 days, receiving either ketone monoester or placebo and completing cognitive assessments

1-2 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ketone Monoester (KE)
Trial Overview The study tests if a supplement called Ketone Monoester (KE) can improve thinking skills compared to a placebo. It looks at how KE affects people differently based on their body type and activity level using brain games, sensorimotor tests, and a driving simulator.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ketone monoester (KME)Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Ketone monoester attenuates declines in cognitive ...Acute ingestion of KME attenuated the decline in cognitive performance during acute severe hypoxic exposure, which coincided with attenuation of ...
The Effects of Exogenous Ketones on Cognitive FunctionThe purpose of this study is to evaluate the acute effects of exogenous ketone monoester (KME) supplementation on cognitive function in three groups of adults ...
The Effect of Exogenous Ketone Bodies on Cognition in ...Results indicate that EK administration has a modest but statistically significant positive effect on cognitive performance (SMD = 0.26, 95% CI: ...
Ketone Ester Effects on Biomarkers of Brain Metabolism ...This is the first study to investigate the AD-biomarker and cognitive effects of KME in humans. Ketone monoester is safe, tolerable, induces robust ketosis.
Effect of ketone monoester supplementation on elite ...In these elite operators, high-altitude mountaineering had a limited impact on cognitive performance, and KME supplementation did not demonstrate any benefit.
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