Trial reportThe journal of nutrition, health & aging2024
Daily consumption of ketone ester, bis-octanoyl (R)-1,3-butanediol, is safe and tolerable in healthy older adults in a randomized, parallel arm, double-blind, placebo-controlled, pilot study.
Trial report in The journal of nutrition, health & aging, 2024. 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 8 papers.
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
8 citing papers in PubMed.
- 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.The Journal of frailty & aging · 2025Trial
- Semaglutide-induced loss of skeletal muscle mass is blunted by co-administration of ketone esters.JCI insight · 2026Article
- Ketogenic Diet Prevents Obesity-Associated Pancreatic Cancer Independent of Weight Loss and Induces Pancreatic Metabolic Reprogramming.Cancer research · 2026Article
- Ketone ester supplementation in aged mice reduces activation of B cell subsets.bioRxiv : the preprint server for biology · 2026Article
- Insights on geroscience pre-clinical and clinical trials to promote healthy aging from the Intrinsic Capacity, Frailty and Sarcopenia Research Task Force 2025.The Journal of frailty & aging · 2026Review
- Review
- Article
- Nutrition and Aging Biology: Summary of a Research Centers Collaborative Network Workshop and Research Needs.Current developments in nutrition · 2025Article
Corrections and comments
- Update of
Authors and funding
13 authors.
Funding
Abstract
objectivesKetone bodies are endogenous metabolites produced during fasting or a ketogenic diet that have pleiotropic effects on aging pathways. Ketone esters (KEs) are compounds that induce ketosis without dietary changes, but KEs have not been studied in an older adult population. The primary objective of this trial was to assess the tolerability and safety of KE ingestion in a cohort of older adults.
designRandomized, placebo-controlled, double-blinded, parallel-arm trial (NCT05585762).
settingGeneral community, Northern California, USA.
participantsCommunity-dwelling older adults, independent in activities of daily living, with no unstable acute medical conditions (n = 30; M = 15, F = 15; age = 76 y, range 65-90 y) were randomized and n = 23 (M = 14, F = 9) completed the protocol.
interventionParticipants were randomly allocated to consume either KE (25 g bis-octanoyl (R)-1,3-butanediol) or a taste, appearance, and calorie-matched placebo (PLA) containing canola oil daily for 12 weeks. MEASUREMENTS: Tolerability was assessed using a composite score from a daily log for 2-weeks, and then via a bi-weekly phone interview. Safety was assessed by vital signs and lab tests at screening and weeks 0, 4 and 12, along with tabulation of adverse events.
resultsThere was no difference in the prespecified primary outcome of proportion of participants reporting moderate or severe nausea, headache, or dizziness on more than one day in a two-week reporting period (KE n = 2 (14.3% [90% CI = 2.6-38.5]); PLA n = 1 (7.1% [90% CI = 0.4-29.7]). Dropouts numbered four in the PLA group and two in the KE group. A greater number of symptoms were reported in both groups during the first two weeks; symptoms were reported less frequently between 2 and 12 weeks. There were no clinically relevant changes in safety labs or vital signs in either group.
conclusionsThis KE was safe and well-tolerated in this study of healthy older adults. These results provide an initial foundation for use of KEs in clinical research with older adults.
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