Trials / Recruiting
RecruitingNCT06962501
Acute Oral Ketone Monoester Supplementation and Resting-state Brain Connectivity
The Impact of Acute Oral Ketone Monoester Supplementation on Resting-state Brain Connectivity in Adults With Cognitive Decline
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- Sponsor
- University Department of Geriatric Medicine FELIX PLATTER · Academic / Other
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | 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. |
Timeline
- Start date
- 2025-04-12
- Primary completion
- 2025-11-01
- Completion
- 2025-11-01
- First posted
- 2025-05-08
- Last updated
- 2025-05-08
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT06962501. Inclusion in this directory is not an endorsement.