Active — Not RecruitingNot Applicable

Effects of Exogenous Ketones on Cognitive Function in Older Adults With Prediabetes?

United States20 participantsStarted 2025-05-20

Plain-language summary

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.

Who can participate

Age range

60 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Regional brain glucose uptake

Timeframe: 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.

Trial details

NCT IDNCT07546409

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-31

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