Targeting Aging With a Ketone Ester for Function in Frailty (NCT06645847) | Clinical Trial Compass
RecruitingNot Applicable
Targeting Aging With a Ketone Ester for Function in Frailty
United States180 participantsStarted 2025-02-05
Plain-language summary
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).
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. Subject is greater than or equal to 65 years of age, inclusive at Screening.
✓. Passes the gait speed criteria at Screening.
✓. Minimum body weight of 50 kgs at Screening.
✓. Subject is willing and able to comply with all study procedures including randomization into any of the experimental groups, maintenance of habitual dietary intake, exercise and medication and supplement use, blood draws and the following prior to test visits: fasting (≥10 h; water only), no alcohol (≥ 10 h), no cannabis products (≥10 h) and no exercise (≥ 10 h).
✓. Subject understands the study procedures and can provide informed consent to participate in the study.
Exclusion criteria
✕. Subject is non ambulatory.
✕. Subject has a CSHA clinical frailty score \> 5.
✕. Subject requires assistance with any activity of daily living, excluding continence.
✕. Subject lives in an institutional setting (skilled nursing facility or residential care facility for the elderly).