Acute Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity

NCT ID: NCT06962501

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-12
• Study Completion Date: 2025-11-01

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)

Detailed 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.

Conditions

MCI; SCD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The impact of acute oral ketone monoester supplementation

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

Group Type: EXPERIMENTAL

Oral ketone monoester (KME)

Intervention Type: 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.

Interventions

Oral ketone monoester (KME)

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

University Department of Geriatric Medicine FELIX PLATTER

OTHER

Sponsor Role: lead

Responsible Party

Sabine Krumm

PD Sabine Krumm, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sabine Krumm, PD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Department of Geriatric Medicine FELIX PLATTER

Locations

University Hospital of Basel

Basel, Canton of Basel-City, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Sabine Krumm, PD, PhD

Role: CONTACT

sabine.krumm@felixplatter.ch

41 61 326 47 66

Jeremy Walsh, PhD

Role: CONTACT

walshj18@mcmaster.ca

Facility Contacts

Sabine Krumm

Role: primary

(sabine.krumm@felixplatter.ch

+41 61 326 47 67

Other Identifiers

2024-02148

Identifier Type: -

Identifier Source: org_study_id