Trial reportThe Journal of frailty & aging2025
Exploratory functional and quality of life outcomes with daily consumption of the ketone ester bis-octanoyl (R)-1,3-butanediol in healthy older adults: a randomized, parallel arm, double-blind, placebo-controlled study.
Trial report in The Journal of frailty & aging, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05585762 (A Randomized, Double-blind, Placebo-controlled, Parallel Group, Feasibility Pilot Study to Evaluate the Tolerability and Safety of a Novel Ketone Ester Ingredient in Healthy Older Men and Women.), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Placebo-controlled, Parallel Group, Feasibility Pilot Study to Evaluate the Tolerability and Safety of a Novel Ketone Ester Ingredient in Healthy Older Men and Women.
Who cites it
1 citing paper in PubMed.
- Ketone ester supplementation in aged mice reduces activation of B cell subsets.bioRxiv : the preprint server for biology · 2026Article
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18 authors.
Funding
Abstract
backgroundKetone bodies are metabolites produced during fasting or on a ketogenic diet that have pleiotropic effects on the inflammatory and metabolic aging pathways underpinning frailty in vivo models. Ketone esters (KEs) are compounds that induce hyperketonemia without dietary changes and that may impact physical and cognitive function in young adults. The functional effects of KEs have not been studied in older adults.
objectivesOur long-term goal is to examine if KEs modulate aging biology mechanisms and clinical outcomes relevant to frailty in older adults. Here, we report the exploratory functional and quality-of-life outcome measures collected during a 12-week safety and tolerability study of KE (NCT05585762).
designRandomized, placebo-controlled, double-blinded, parallel-group, pilot trial of 12-weeks of daily KE ingestion.
settingThe Clinical Research Unit at the Buck Institute for Research on Aging, California.
participantsCommunity-dwelling older adults (≥65 years), independent in activities of daily living, with no unstable acute medical conditions (n = 30).
interventionParticipants were randomly allocated (1:1) to consume 25 g daily of either KE (bis-octanoyl (R)-1,3-butanediol) or a taste, appearance, and calorie-matched placebo (PLA) containing canola oil. MEASUREMENTS: Longitudinal change in physical function, cognitive function and quality of life were assessed as exploratory outcomes in n = 23 completers (n = 11 PLA, n = 12 KE). A composite functional outcome intended for interventional frailty trials was derived and calculated. Heart rate and activity was measured throughout the study using digital wearables.
resultsThere were no statistically significant longitudinal differences between groups in exploratory functional, activity-based or quality of life outcomes.
conclusionDaily ingestion of 25 g of KE did not affect exploratory functional or quality-of-life end points in this pilot cohort of healthy older adults. Future work will address these endpoints as primary and secondary outcomes in a larger trial of pre-frail older adults.
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