MCINCT06962501
Acute Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity
A study testing Oral ketone monoester (KME) in people with MCI and SCD, run by University Department of Geriatric Medicine FELIX PLATTER at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 years and older
- What is being tested?
- Oral ketone monoester (KME)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Apr 2025to 18 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Basel
Basel, Canton of Basel-City, 4031
About this study
Official title: The Impact of Acute Oral Ketone Monoester Supplementation on Resting-state Brain Connectivity in Adults With Cognitive Decline
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:
Read more
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)
Read the 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.
- Being tested
- Oral ketone monoester (KME)
- Keywords
- keton, MCI, SCD, CBF, DMN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Dietary Supplement: Oral ketone monoester (KME) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 minutes
Secondary outcomes (1)
Cerebral blood flow
Sum of blood flow in the internal carotid and vertebral arteries via phase contrast MRI in ml/min.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start12 Apr 2025
- Primary completion18 Apr 2026
- Study completion18 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MCIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTER
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Sabine Krumm, University Department of Geriatric Medicine FELIX PLATTER
- Investigators
- Sabine Krumm, PD, PhD, Principal investigator, University Department of Geriatric Medicine FELIX PLATTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962501
- Sponsor's protocol ID
- 2024-02148
- Status last verified
- May 2026
- First submitted
- 9 Apr 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Trial and participant data will be handled with uttermost discretion and is only accessible to authorised personnel who require the data to fulfil their duties within the scope of the study.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Acute Oral Ketone Monoester Supplementation on Resting-state Brain Connectivity in Adults With Cognitive Decline
- ClinicalTrials.gov ID
- NCT06962501
- Acronym / sponsor ID
- 2024-02148
- Keywords
- keton, MCI, SCD, CBF, DMN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Department of Geriatric Medicine FELIX PLATTERUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 12 Apr 2025 (actual)
- Primary completion
- 18 Apr 2026 (actual)
- Study completion
- 18 Apr 2026 (actual)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The impact of acute oral ketone monoester supplementation | Experimental | Dietary Supplement: Oral ketone monoester (KME)Single dose of a ketone monoester ([R]-3-hydroxybutyl [R]-3-hydroxybutyrate; 0.3 g β-OHB/kg body weight) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults aged 55 years or older
- Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | The impact of acute oral ketone monoester supplementation |
Primary outcome
Functional connectivity of the DMN
Time frame: 90 minutes
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.
1 secondary outcome
Cerebral blood flow
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No. Trial and participant data will be handled with uttermost discretion and is only accessible to authorised personnel who require the data to fulfil their duties within the scope of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Krumm, PD, PhD principal investigator
University Department of Geriatric Medicine FELIX PLATTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral ketone monoester (KME) in people with MCI and SCD, run by University Department of Geriatric Medicine FELIX PLATTER at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional connectivity of the DMN (time frame: 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.