Effects of a ketone supplement on brain connectivity in older adults
The Impact of Acute Oral Ketone Monoester Supplementation on Resting-state Brain Connectivity in Adults With Cognitive Decline
This study is testing if a single dose of a ketone supplement can improve brain blood flow and connectivity in older adults with early signs of memory problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University Department of Geriatric Medicine FELIX PLATTER Academic / other |
| Locations | 1 site (Basel, Baselstadt) |
| Trial ID | NCT06962501 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the impact of a single dose of an oral ketone monoester supplement on cerebral blood flow and brain connectivity in adults aged 55 and older with subjective cognitive decline (SCD) or mild cognitive impairment (MCI). Participants will undergo two MRI scans to assess changes in brain function before and after consuming the supplement. The study aims to determine if the ketone supplement can enhance blood flow and connectivity in the Default Mode Network, which is crucial for cognitive function. Additionally, the study will measure capillary blood ketone levels and hemodynamic parameters during the session.
Who should consider this trial
Good fit: Ideal candidates are adults aged 55 and older experiencing subjective cognitive decline or mild cognitive impairment.
Not a fit: Patients with significant cognitive decline due to specific diseases or disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to improve cognitive function in older adults at risk of dementia.
How similar studies have performed: While the approach of using ketone supplementation is relatively novel, preliminary studies suggest potential benefits in cognitive function, indicating a promising area of exploration.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel, Baselstadt
- University Hospital of Basel — Basel, Baselstadt, Switzerland (Recruiting)
Study contacts
- Principal investigator: Sabine Krumm, PD, PhD — University Department of Geriatric Medicine FELIX PLATTER
- Study coordinator: Sabine Krumm, PD, PhD
- Email: sabine.krumm@felixplatter.ch
- Phone: 41 61 326 47 66
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.