Acute Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity

University Department of Geriatric Medicine FELIX PLATTER

Status

Enrolling

Conditions

MCI

SCD

Treatments

Dietary Supplement: Oral ketone monoester (KME)

Study type

Interventional

Funder types

Other

Identifiers

NCT06962501

2024-02148

Details and patient eligibility

About

The primary objectives of this pilot study are to test if a single dose of an oral ketone monoester supplement will increase blood flow and connectivity in the brain in adults with subjective cognitive decline (SCD) or mild cognitive impairment (MCI).

The main questions it aims to answer are:

Does a single dose of an oral ketone supplement increase global cerebral blood flow (CBF)?

Does a single dose of an oral ketone supplement improve resting-state functional connectivity in the Default Mode Network (DMN)?

Does the increase in CBF positively correlate with improved functional connectivity in the DMN?

Participants will:

Attend one 2-hour session, which includes:
Neurocognitive assessment
MRI Scans (two, each 15 Minutes)
Capillary blood ketone level measurements
Hemodynamic assessment (blood pressure, heart rate)

Full description

In this non-randomized, single-arm study participants will undergo a baseline MRI scan to assess functional connectivity in the DMN and resting CBF without ketone supplementation. Participants will then consume 0.3 g/kg body weight of a ketone monoester supplement (∆G Tactical) and then rest for 70 minutes. Participants will then undergo a second MRI scan to evaluate changes in functional connectivity and CBF, with capillary β-OHB and blood pressure measured before and after each scan. The entire experimental visit, including scans and assessments, will last up to 2 hours.

Enrollment

22 estimated patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults aged 55 years or older
Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI)

SCD CRITERIA:

Self-experienced, persistent decline of cognitive abilities within the last 5 years in relation to a previously normal status
Normal results on demographically adjusted standardized cognitive tests
Accompanied by concerns associated with SCD and a feeling of worse performance than others in the same age group
Decline must not be related to a specific event or explained by a specific disease, medical disorder, medication, or substance abuse

MCI CRITERIA

Fulfils criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5):
Demographically adjusted performance between -1 and -2 SD below average in one or more cognitive domains on standardized cognitive tests
Accompanied by concern from the individual, a knowledgeable informant, or clinician indicating mild cognitive decline
Capacity for independent daily activities is maintained

Exclusion criteria

Clinical diagnoses of psychiatric disorders (e.g., anxiety disorders, depression)
Diagnosed major neurocognitive disorder (i.e., dementia)
Association of SCD or MCI with delirium
Diagnosed cardiometabolic disease (Uncontrolled hypertension (systolic blood pressure >160 mm Hg, and/or diastolic blood pressure >100 mm Hg, Type 2 diabetes)
Substance use disorder
History of heart attack or stroke requiring hospitalization in the past 3 years
MRI contraindications, including implanted medical devices
Experiencing residual fatigue, brain fog, or tiredness post-acute illness (i.e., long-COVID)
Severe literacy, visual, hearing, and/or speech impairment that would make participation in the study difficult or impossible
Individuals who are not fluent in Swiss German or German