Acute Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity

NCT06962501 | Recruiting

• 1 other identifier: 2024-02148
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

MCI; SCD

Keywords

keton; MCI; SCD; CBF; DMN

Outcome Measures

Primary Outcomes (1)

• Functional connectivity of the DMN

  Functional connectivity of the default mode network (DMN) is measured via functional MRI. Changes in BOLD signal in each region are determined by independent component analysis and then functional connectivity is measured as a Pearson correlation (r) between the neural regions comprising the DMN and transformed into a z score.

  90 minutes

Secondary Outcomes (1)

• Cerebral blood flow

  90 minutes

Other Outcomes (3)

• Plasma β-OHB

  90 minutes

• Arterial blood pressure

  90 minutes

• Heart Rate

  90 minutes

Study Arms (1)

The impact of acute oral ketone monoester supplementation

EXPERIMENTAL

Single dose of a ketone monoester (\[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate; 0.3 g β-OHB/kg body weight)

Dietary Supplement: Oral ketone monoester (KME)

Interventions

Oral ketone monoester (KME) DIETARY_SUPPLEMENT

The oral ketone monoester supplement should increase the global CBF and improve resting-state connectivity in the DMN in adults with SCD or MCI. The participants will take one dose of the supplement followed by measurement, to figure out if there are any noticeable changes.

The impact of acute oral ketone monoester supplementation

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Department of Geriatric Medicine FELIX PLATTER: lead
• McMaster University: collaborator

Study Sites (1)

University Hospital of Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

Study Officials

• Sabine Krumm, PD, PhD

  University Department of Geriatric Medicine FELIX PLATTER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Krumm, PD, PhD

CONTACT

41 61 326 47 66; sabine.krumm@felixplatter.ch

Jeremy Walsh, PhD

CONTACT

walshj18@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Sabine Krumm, PhD

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: May 8, 2025
• Study Start: April 12, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)