What this study is
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.
What's being tested
- Ketone Monoester (KE)
Intervention · DIETARY SUPPLEMENT
The 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
Intervention · DIETARY SUPPLEMENT
The 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.
Study details
- Official title
- Can Exogenous Ketone Supplementation Compensate for Glucose Hypometabolism and Improve Cognitive Processing Speed in Veterans With Prediabetes?
- Sponsor
- University of Alabama at Birmingham
- Conditions
- Prediabetes · Healthy (Controls)
- Enrolling
- 20 people
- Starts
- 2025-05-20
- Est. completion
- 2026-05-31
- Design
- Triple-blind, randomized, crossover
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 60 Years – 75 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Age 60 to 75 years
- Able to provide written informed consent
- Fluent in English
- No diagnosed cognitive impairment or dementia Classified as either:; Prediabetes (based on American Diabetes Association criteria), or Normal glucose regulation (control group); Medically stable and cleared to undergo positron emission tomography and magnetic resonance imaging; Willing to comply with study procedures, including metabolic testing, supplement ingestion, and neuroimaging
You can't join if
- 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)
- Major psychiatric disorder not stable on treatment
- Uncontrolled hypertension or significant cardiovascular disease
- Severe renal, hepatic, or gastrointestinal disease that may affect supplement metabolism
- Contraindications to magnetic resonance imaging (e.g., non-compatible implanted devices, severe claustrophobia)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openUAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Webb Nutrition Sciences Building
Birmingham, Alabama, United States
Study team
Sponsor
University of Alabama at Birmingham
Study ID IRB-300013058
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.