At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A clinical study evaluating Ketone ester and Non-ketone placebo for Tolerance and 2 related conditions. Completed, enrolled 30 participants across 1 site.
Detailed Summary
This study is to investigate the tolerability and safety of a ketone promoting ingredient, called a ketone ester (KE), in healthy older adults. This randomized, double-blind, placebo-controlled trial aims to characterize the tolerability and safety of daily consumption of the KE in healthy older adults (over 65 years old) over 12 weeks. Study participants will complete Beverage Tolerability Questionaires (BTQ) to rate any side side effects throughout the study. Safety will also be assessed by collection of blood and urine samples, vital signs, body weight, and monitoring of adverse events (AEs). The study will also collect pilot data to explore possible effects of KE on physical function, cognitive function and quality of life. The findings of this study will be used to facilitate future mechanistic studies of KE in aging.
Study Details
Timeline
Interventions
75 mL chocolate flavored beverage containing 25 g of ketone ester. Half a bottle (12.5 g/day) will be consumed for the first 7 days and a complete bottle (25 g/day) will be consumed for the remaining 77 days.
75 mL chocolate flavored beverage containing 25 g of non-ketogenic fat. Half a bottle (12.5 g/day) will be consumed for the first 7 days and a complete bottle (25 g/day) will be consumed for the remaining 77 days.