Exogenous Ketones for Prediabetes

Not currently recruiting at 1 trial location

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have prediabetes or normal blood sugar levels.
* 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
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete metabolic testing to determine glucose status and undergo brain imaging using 18FDG-PET/MRI while performing a cognitive processing speed task

1 day
1 visit (in-person)

Intervention

Participants consume a single dose of a commercially available ketone monoester supplement and complete cognitive testing during imaging to measure processing speed and brain activity

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in cerebral glucose uptake and cognitive performance between placebo and ketone conditions

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Exogenous Ketones

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: KetoneExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+