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The Effect of Ketone Monoester on Cognition in Neurotypical People of Different Ages

The Effect of Ketone Monoester on Cognition in Neurotypical People of Different Ages - KME Cognition

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57760
Enrollment
80
Registered
2025-06-16
Start date
2025-06-23
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enhancement of Cognitive Performance in Healthy Participants Cognition Memory

Interventions

Test subjects consume either two doses (0.3 g per kg body weight and 0.2 g per kg of body weight) of the Ketone Monoester (KME) or the same doses of the placebo with the same taste and volume during

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1.) Between ages 18-28 for participants in the *young* group Between ages 65-85 for participants in the *old* group 2.) Able to understand English at least on B1 level (applies to half of participants who will undergo the EEG-ERP scan where set of congruent and incongruent english words are played) 3.) Normal, or corrected-to-normal vision 4.) Willing to give informed consent for participating in the study 5.) Willing to refrain from any psychoactive substances (except for caffeine) for 24 hours before the in-person study session 6.) Willing to refrain from caffeine for 3 hours before the start of the study session 7.) Willing to come in an overnight fasted state to the study sessions 8.) Willing to undergo a finger-prick for obtaining a blood sample

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1.) Taking psychoactive medication now or in the past 6 months 2.) Neurological/Psychiatric Diagnosis 3.) Diagnosis of type 2 diabetes, type 1 diabetes or prediabetes 4.) Consuming a ketogenic diet or practicing longer than 24h fasts in 1 month preceding the study 5.) Colour blindness 6.) Being pregnant or lactating 7.) Hearing disorder preventing subjects from performing the EEG-ERP scan 8.) Food allergies incompatible with the investigational drinks 9.) Unhealthy scalp (apparent open wounds and/or bruised or weakened skin; applicable only to participants in the EEG group)

Design outcomes

Primary

MeasureTime frame
Cognitive test scores measured by the adaptive n-back test (accuracy and reaction time) and task-switching test (accuracy and reaction time).

Secondary

MeasureTime frame
EEG event-related potentials evaluated (N100, P300, and N400 latencies and amplitudes) via the Neurocatch device. Self-perceived workload will be assessed by modified NASA Task Load Index (Hart, 1986). Affect grid (Russell 1989) will be used to assess mood and arousal. Blood D-BHB levels evaluated using a handheld ketone meter (Keto Mojo, EU).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)