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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.
Awards & highlights

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 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

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.

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.
Continuous renal replacement therapy with regional citrate anticoagulation: do we really know the details?[Interests in angiogenesis inhibitor drugs approved for the treatment of cancers].

Find a Location

Who is running the clinical trial?

Buck Institute for Research on AgingLead Sponsor
3 Previous Clinical Trials
520 Total Patients Enrolled
Biofortis Mérieux NutriSciencesOTHER
18 Previous Clinical Trials
2,551 Total Patients Enrolled
John C Newman, MD, PhDPrincipal InvestigatorBuck Institute

Media Library

Ketone Ester (Ketone Ester) Clinical Trial Eligibility Overview. Trial Name: NCT05585762 — N/A
Safety Concerns Research Study Groups: Ketone ester, Non-ketone placebo
Safety Concerns Clinical Trial 2023: Ketone Ester Highlights & Side Effects. Trial Name: NCT05585762 — N/A
Ketone Ester (Ketone Ester) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05585762 — N/A
~11 spots leftby Oct 2025