Targeting Aging With a Ketone Ester for Function in Frailty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorBuck Institute for Research on Aging
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Ketone ester
Other interventionKetone ester (KE) (Chemical name: Bis-octanoyl-(R)-1,3-butanediol, Common name: C8 ketone di-ester) formulated as a dietary supplement. KE 12.5 g per day for 1 week; followed by KE 25 g per day for 1 week; followed by KE 37.5 g per day split into two doses for 1 week; followed by KE 50 g per day split into two doses for 17 weeks
Placebo Comparator: Non-ketone placebo
Other interventionPlacebo oil (non-ketogenic canola oil) formulated as a dietary supplement. Placebo oil 12.5 g per day for 1 week; followed by Placebo oil 25 g per day for 1 week; followed by Placebo oil 37.5 g per day split into two doses for 1 week; followed by Placebo oil 50 g per day split into two doses for 17 weeks
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Ketone esterActive comparator 1 intervention
Group B: Non-ketone placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Frailty composite score
The primary outcome measure is the difference in the change in a four-item composite score of vigor-frailty (6 minute walk, 1 rep max leg press, digit symbol substitution, Pittsburg Fatigability Scale - Physical sub scale) over 20 weeks between groups. The original composite score was developed by the Study of Muscle Mass and Aging Group, it is continuous, and a higher score corresponds to better function.
Time frame
Baseline, 12 weeks, 20 weeksSecondary outcomes
1
Tolerability key symptom index
Proportion of subjects reporting the same moderate to severe symptom (among dizziness, headache or nausea) occurring on more than one day within any given recall period (after week 0 - 2 acclimation period) when ketone esters are consumed daily for 20 weeks.
Time frame
20 weeks2
Safety Lab Tests
Changes in clinical laboratory measurements when ketone esters are consumed daily for 20 weeks.
Time frame
Baseline, Week 4, Week 12, 20 weeks3
Leg fatigue - leg press at sub maximal weight
Difference in change in number of repetitions completed on the leg press machine at a sub maximal weight (subject must complete as many repetitions as they can).
Time frame
20 weeks4
Short Physical Performance Battery
Difference in change in Short Physical Performance Battery score
Time frame
Baseline, Week 12, 20 weeksOther outcomes
1
Immune phenotyping
Differences in cell subtypes, markers of immune aging and exhaustion, metabolite transporters and systemic inflammation.
Time frame
20 weeks2
Changes in gut microbial diversity
DNA sequencing of bacterial species in stool samples.
Time frame
Baseline, Week 1, Week 4, Week 12, Week 203
Profile of Mood States
Questionnaire about mood
Time frame
Baseline, Week 12, Week 204
Lower Urinary Tract Symptoms Questionnaire
Score on questionnaire assessing lower urinary tract symptoms
Time frame
Baseline, week 12, week 20Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Buck Institute for Research on Aging
Lead sponsor
Ohio State University
Collaborator
University of Connecticut
Collaborator
California Pacific Medical Center Research Institute
Collaborator
Source ClinicalTrials.gov