20 Participants NeededMy employer runs this trial

Exogenous Ketones for Prediabetes

Recruiting at 1 trial location
KS
Overseen ByKatherine Sweatt, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether older adults with prediabetes differ in brain energy use and thinking speed compared to those with normal blood sugar. It also examines whether a ketone supplement (exogenous ketones) can temporarily enhance brain function and thinking speed. Participants will undergo brain scans and cognitive tests before and after taking the supplement. Older adults aged 60 to 75 who are medically stable and have prediabetes or normal glucose levels may be suitable candidates. The results could reveal whether early metabolic issues relate to brain energy use and if ketones benefit those at risk for dementia. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new insights into brain health and dementia prevention.

Will I have to stop taking my current medications?

If you are taking glucose-lowering medications like insulin or metformin, you will need to stop, as the trial excludes participants using these medications.

What prior data suggests that this exogenous ketone supplement is safe for older adults with prediabetes?

Past research has generally found that taking extra ketones is safe and well-tolerated. One study showed that regular use for a month was safe and even helped control blood sugar in people with type 2 diabetes. Another study found that a single dose can lower blood sugar levels without affecting insulin, which is important for managing blood sugar. While extra ketones are mostly considered safe for healthy adults, they may have some downsides. Overall, evidence suggests that taking extra ketones is safe for most people, especially when used occasionally.12345

Why are researchers excited about this trial?

Unlike the standard treatments for prediabetes, which often include lifestyle changes and medications like metformin to regulate blood sugar, exogenous ketones offer a novel approach. These ketones mimic the effects of a ketogenic diet by providing an alternative energy source to glucose, potentially improving insulin sensitivity and reducing blood sugar levels without drastic dietary changes. Researchers are excited about this treatment because it could offer a more flexible and less restrictive option for managing prediabetes, potentially enhancing patient adherence and outcomes.

What evidence suggests that exogenous ketones might be an effective treatment for prediabetes?

Research has shown that ketone supplements can lower blood sugar levels and improve certain brain functions. In this trial, participants in the ketone arm will receive exogenous ketones. Studies have found that these supplements can reduce blood sugar by about 9.7 mg/dL, potentially aiding individuals with prediabetes in managing their blood sugar. Additionally, ketone supplements increase ketone levels in the blood, providing an alternative energy source for the brain. This is promising because it might enhance brain function, especially for those whose brains don't use glucose effectively, such as some people with prediabetes.16789

Are You a Good Fit for This Trial?

This trial is for adults aged 60-75 who are medically stable, fluent in English, and have either prediabetes or normal blood sugar. Participants must not have diagnosed dementia or cognitive impairment and must be able to undergo brain scans and follow study procedures.

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

Trial Overview

The study tests whether a single dose of a ketone supplement (ketone monoester) can improve brain energy use and thinking speed in older adults with prediabetes compared to those with normal glucose levels. Some participants receive the supplement; others get a placebo.

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+

Citations

Effects of Exogenous Ketone Supplementation on Blood ...

The available evidence indicates that acute ingestion of exogenous ketones leads to increased blood BHB and decreased blood glucose.

Effects of Exogenous Ketones on Cognitive Function in Older ...

The goal of this clinical trial is to learn whether older adults with prediabetes, but no diagnosed cognitive impairment, show early changes in ...

Exogenous Ketones Lower Blood Glucose Level in Rested ...

These results support the conclusion that exogenous ketone supplements have potential value in inducing therapeutic ketosis and reducing blood glucose levels.

NCT05155410 | Examining the Effect of Exogenous Ketone ...

The main objective of this study is to determine if consuming a ketone supplement 3 times per day (before meals) for 14 days lowers blood sugar.

Exogenous ketone supplementation: an emerging tool for ...

Existing human studies report that exogenous ketones can lower blood glucose and improve some aspects of cognitive function, highlighting the ...

The effect of acute and 14-day exogenous ketone ...

Exogenous ketone supplements can acutely lower blood glucose, suggesting therapeutic potential in individuals with impaired glucose metabolism.

Effects of Exogenous Ketones on Cognitive Function in ...

The goal of this clinical trial is to learn whether older adults with prediabetes, but no diagnosed cognitive impairment, show early changes in ...

Exogenous ketosis in patients with type 2 diabetes - PMC - NIH

Constant ketone monoester consumption over 1 month was safe, well tolerated, and improved glycaemic control in patients with type 2 diabetes.

How do exogenous ketones affect blood glucose and ...

Exogenous ketone supplements acutely increased levels of blood ketones and reduced blood glucose but didn't affect insulin levels.