Effects of Exogenous Ketones on Cognitive Function in Older Adults With Prediabetes?
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-75
SponsorUniversity of Alabama at Birmingham
About this trial
Brief Summary
The goal of this clinical trial is to learn whether older adults with prediabetes, but no diagnosed cognitive impairment, show early changes in brain energy use and thinking speed compared to older adults with normal blood sugar levels. The study will also test whether a single dose of an exogenous ketone supplement can improve brain energy use and cognitive processing speed.
The main questions it aims to answer are:
Do older adults with prediabetes have lower brain glucose uptake and slower cognitive processing speed compared to those with normal glucose levels?
Does a single dose of an exogenous ketone monoester supplement improve cognitive processing speed and brain glucose uptake?
Researchers will compare older adults with prediabetes to older adults with normal glucose levels to determine whether differences exist in brain glucose metabolism and cognitive performance. In a subset of participants, researchers will also compare brain and cognitive outcomes before and after consuming a ketone monoester supplement (DeltaG, Oxford, England).
Participants will:
Complete metabolic testing to determine glucose status
Undergo brain imaging using fluorodeoxyglucose positron emission tomography combined with magnetic resonance imaging (18FDG-PET/MRI) while performing a cognitive processing speed task
Consume a single dose of a commercially available ketone monoester supplement during one study visit
Complete cognitive testing during imaging to measure processing speed and brain activity
The results of this study will help determine whether early metabolic dysfunction is linked to reduced brain energy use and whether ketones can temporarily support brain function in individuals at risk for dementia.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 60 to 75 years
Able to provide written informed consent
Fluent in English
No diagnosed cognitive impairment or dementia
Disqualifiers
Diagnosis of mild cognitive impairment, dementia, or other neurodegenerative disorder
Diagnosis of type 1 diabetes or type 2 diabetes
Use of glucose-lowering medications (e.g., insulin, metformin, glucagon-like peptide-1 receptor agonists)
History of major neurological disorder (e.g., stroke, traumatic brain injury with loss of consciousness >30 minutes, epilepsy, multiple sclerosis)
Trial design
Design model
Crossover
Treatments tested in this trial
Ketone Monoester (KE)
Dietary supplementThe intervention is a single acute oral dose of a commercially available ketone monoester supplement (DeltaG®, Oxford, England). The active ingredient, (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, is rapidly metabolized after ingestion to raise circulating beta-hydroxybutyrate concentrations without requiring dietary carbohydrate restriction or fasting. The supplement is administered under supervised conditions during a study visit. Brain imaging with fluorodeoxyglucose F18 positron emission tomography combined with magnetic resonance imaging is performed during the post-ingestion period while participants complete a cognitive processing speed task. This protocol evaluates the immediate metabolic and neurocognitive effects of exogenous ketone administration within a single session.
Placebo
Dietary supplementThe placebo consists of a taste-, color-, and volume-matched beverage formulated to mimic the sensory characteristics of the ketone monoester supplement but containing no active ketone ingredient. The placebo does not contain (R)-3-hydroxybutyl (R)-3-hydroxybutyrate) and does not elevate circulating beta-hydroxybutyrate concentrations. The placebo beverage will be administered orally under supervised research conditions during a study visit using procedures identical to the active supplement condition. Brain imaging with fluorodeoxyglucose F18 positron emission tomography combined with magnetic resonance imaging will be performed during the post-ingestion period while participants complete a cognitive processing speed task. This control condition allows isolation of the metabolic effects of ketone elevation from expectancy or beverage-related effects.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: KetoneExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Regional brain glucose uptake
Regional brain glucose uptake measured by fluorodeoxyglucose F18 positron emission tomography. The primary outcome is regional cerebral glucose uptake quantified using fluorodeoxyglucose F18 positron emission tomography integrated with magnetic resonance imaging. Glucose uptake will be assessed in prespecified frontal and temporoparietal regions implicated in early metabolic and cognitive decline. Uptake values will be expressed as standardized uptake value ratios to allow regional comparison across participants. This outcome is used to determine (1) whether older adults with prediabetes exhibit reduced task-related brain glucose uptake compared to metabolically normal older adults, and (2) whether acute ketone monoester ingestion alters regional glucose uptake during cognitive task performance.
Time frame
Two visits (placebo and ketone condition in random order) will take place within 4 weeks of enrollment. Main outcome is change in cerebral glucose uptake between placebo and ketone conditions.Sponsors and contacts
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Source ClinicalTrials.gov