Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
Healthy Volunteers
NCT06645847

Targeting Aging With a Ketone Ester for Function in Frailty

Led by Buck Institute for Research on Aging · Updated on 2026-03-13

180

Participants Needed

3

Research Sites

164 weeks

Total Duration

On this page

Sponsors

B

Buck Institute for Research on Aging

Lead Sponsor

O

Ohio State University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study aims to find out if a food supplement that contains a naturally occurring substance, ketones, can help to improve strength and general wellness in adults at, or over the age of 65 years who are experiencing a slight decline in their physical function. Participation will involve a screening visit and 4 additional study visits over the course of 20 weeks. After being assessed for eligibility, study participants will be sorted into two groups at random and consume either a ketone or placebo supplement at home every day for 20 weeks. Both study products can cause gastro-intestinal side effects in some individuals. At all study visits, subjects will provide blood samples. At three study visits, subjects will be asked to complete physical performance tests, provide blood, stool and urine samples. They will also complete questionnaires during three study visits to assess physical function, markers of inflammation, and other aspects of general well-being. The study enrolls at three sites across the United States, in California (Buck Institute), Ohio (Ohio State University), and Connecticut (University of Connecticut). The study is coordinated by the San Francisco Coordinating Center (California Pacific Medical Center).

CONDITIONS

Official Title

Targeting Aging With a Ketone Ester for Function in Frailty

Who Can Participate

Age: 65Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 years or older at screening
  • Passes the gait speed criteria at screening
  • Minimum body weight of 50 kilograms at screening
  • Willing and able to comply with all study procedures, including fasting and avoiding alcohol, exercise, and cannabis for at least 10 hours before test visits
  • Able to understand study procedures and provide informed consent
Not Eligible

You will not qualify if you...

  • Unable to walk without assistance
  • Clinical frailty score greater than 5
  • Requires help with any activity of daily living, except continence
  • Lives in a skilled nursing or residential care facility
  • Female who has not passed menopause
  • Unable to communicate in English or Spanish (if available at the site)
  • Hospitalized within 30 days before screening
  • Physical limitations preventing leg press testing
  • Abnormal lab results indicating unstable major organ disease
  • Uncontrolled high cholesterol
  • History or presence of severe or active pulmonary, cardiac, liver, kidney, endocrine, blood, immune, nervous system, psychiatric, or biliary disorders
  • Significant gastrointestinal conditions affecting study beverage evaluation
  • Heavy alcohol use (women: 8+ drinks/week; men: 15+ drinks/week)
  • History of alcohol or substance abuse
  • Medical instructions to avoid alcohol
  • Known allergy or sensitivity to any study beverage ingredients
  • Uncontrolled high blood pressure
  • Active or recently treated cancer (except non-melanoma skin cancer)
  • Immunosuppressive disorders or medications
  • Chronic antibiotic use during study period
  • Extreme dietary habits or recent weight-loss programs
  • Recent ketogenic diet or ketone supplement use
  • Conditions interfering with consent or study compliance
  • Work schedules preventing consistent meal timing

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Buck Institute for Research on Aging

Novato, California, United States, 94945

Actively Recruiting

2

UConn Health

Farmington, Connecticut, United States, 06030

Actively Recruiting

3

Ohio State University

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

B

Brianna Stubbs, DPhil

CONTACT

C

Chatura Senadheera, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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