Clinical Trials Directory

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

TypeNameDescription
DIETARY_SUPPLEMENTOral 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.