What is the mechanism of action of this treatment?

Ketone esters (KE) work by promoting the production of ketones, which are alternative energy sources for the body, especially the brain, when glucose is not readily available. This mechanism is particularly relevant for older adults as it may support cognitive function and physical performance. Understanding the safety and tolerability of KE is crucial because it ensures that the benefits of improved energy metabolism do not come with adverse side effects, which is essential for maintaining overall health and quality of life in this population.

What side effects are associated with this type of intervention?

The trial on ketone ester (KE) focuses on its tolerability and safety in older adults. Common side effects reported include dizziness, impaired gait, and nasal discomfort, which are generally transient. Persistent adverse effects noted were pain on urination in some patients. For similar metabolic treatments, such as omega-3 fatty acids, side effects can include gastrointestinal discomfort and, in rare cases, increased bleeding risk. Alpha-lipoic acid, another metabolic agent, has been associated with gastrointestinal issues and skin rash. Overall, these treatments are generally well-tolerated but can have specific side effects that should be monitored.

What prior FDA approvals exist?

There are no specific FDA-approved treatments that directly promote ketone production similar to the Ketone Ester being studied in the trial. However, the FDA has approved various treatments for other conditions that have undergone rigorous safety and tolerability assessments. For example, drugs like cannabidiol (CBD) for epilepsy and dimethyl fumarate for multiple sclerosis have been approved after extensive trials to ensure their safety and efficacy. These approvals highlight the FDA's commitment to ensuring that new treatments are both safe and effective for patients.

What other types of research exist?

Promising novel alternatives to Ketone Ester for patients with safety concerns include: 1) Glucagon-like peptide 1 (GLP-1) agonists, which have shown efficacy in improving metabolic health and have a well-documented safety profile. 2) Noninvasive neuromodulation techniques, which have demonstrated relief in conditions like essential tremor and may offer benefits for metabolic regulation without significant side effects. 3) Emerging pharmacologic agents targeting obesity pathways, which are closer to clinical application and have shown potential in both animal and human studies.

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Ketone Ester

Ketone Ester for Aging (BIKE Trial)

N/A

Waitlist Available

Led By John C Newman, MD, PhD

Research Sponsored by Buck Institute for Research on Aging

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from pre-test to week 1, week 4 and week 12.

Summary

This trial is testing a special drink that increases ketone levels in healthy adults over 65. The goal is to see if the drink is safe and well-tolerated, and to explore its potential benefits on physical and mental functions. Ketones provide an alternative energy source for the body, which might be helpful for older adults.

Who is the study for?

Healthy older adults over 65 with a BMI of 18.5-34.9 kg/m2 can join this trial if they have no major health issues, are not on certain medications, and haven't used ketone supplements recently. They must be able to follow the study's diet and exercise guidelines, provide informed consent, and not require assistance with daily living or live in an institution.

What is being tested?

The trial is testing the safety and tolerability of a ketone ester (KE) compared to a non-ketone placebo over 12 weeks in healthy seniors. It involves daily consumption of KE, monitoring through questionnaires, blood/urine tests, vital signs checks, body weight tracking, and assessing any adverse events.

What are the potential side effects?

Possible side effects from consuming the ketone ester may include digestive discomfort as reported by participants using Beverage Tolerability Questionnaires. Blood and urine tests will help monitor for other potential side effects related to organ function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from pre-test to week 1, week 4 and week 12.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from pre-test to week 1, week 4 and week 12.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from pre-test to week 1, week 4 and week 12. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tolerance

Secondary study objectives

Ketone changes 4h after ketone ester drinks

Safety Blood Profile

Other study objectives

Change in 1 rep max leg press

Change in 6 minute walk test

Change in Digit Symbol Substitution Task scores

+13 more

Side effects data

From 2023 Phase 2 trial • 26 Patients • NCT04633460

15%

Dizziness

10%

Reflux

Fatigue

Hematoma

Knee pain

Laryngeal inflammation

Upper respiratory tract infection

Headache

Cough

Muscle cramp

100%

80%

60%

40%

20%

Study treatment Arm

Ketone Ester

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ketone esterExperimental Treatment1 Intervention

Flavored ketone ester beverage 75 mL. Day 0 - 7: half of one bottle consumed daily. Day 8 to end (Week 12): one full bottle consumed daily.

Group II: Non-ketone placeboPlacebo Group1 Intervention

Flavored beverage with bitter additive 75 mL. Matched for appearance, taste and calories. Day 0 - 7: half of one bottle consumed daily. Day 8 to end (Week 12): one full bottle consumed daily.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Ketone esters (KE) work by promoting the production of ketones, which are alternative energy sources for the body, especially the brain, when glucose is not readily available. This mechanism is particularly relevant for older adults as it may support cognitive function and physical performance. Understanding the safety and tolerability of KE is crucial because it ensures that the benefits of improved energy metabolism do not come with adverse side effects, which is essential for maintaining overall health and quality of life in this population.

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