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Tortoriello Romero, Juan Pablo

University of British Columbia

The potential therapeutic effects of ketosis have recently garnered attention in the scientific community and lay public. Although typically achieved by fasting or following a restrictive very-low carbohydrate diet, ketosis can now be achieved through exogenous ketone supplements, which have been shown to lower glucose and improve heart function, making them a potential therapeutic option in type 2 diabetes. However, studies conducted to date are short-term and many questions remain related to feasibility of longer-term exogenous ketone supplementation. The purpose of this research was to conduct a remote randomized double-blind, placebo-controlled pilot trial to assess the feasibility of 90 days of exogenous ketone supplementation in people living with type 2 diabetes. Twenty individuals living with type 2 diabetes were randomized to consume an exogenous ketone supplement (n=10, 59 mL of flavored concentrate containing 5 g free beta-hydroxybutyric acid + 5 g of the ketone precursor 1,3-butanediol) or a volume, taste- and pH-matched placebo (n=10) three times per day for 90 days. All trial procedures were conducted remotely. The main feasibility outcomes were recruitment rate, compliance/adherence, and participant retention/completion of the trial. Preliminary efficacy outcomes included blood glucose regulation (hemoglobin A1c, continuous glucose monitoring), cardiovascular disease risk factors (waist circumference, blood pressure, blood lipids), and general health questionnaires (physical activity, general health perception, food cravings, and dietary intake). Twenty participants were recruited primarily through specialized third-party social media advertising across ~6 months. Four participants dropped out of the exogenous ketone group due to gastrointestinal issues (n=2) or urge to vomit (n=2) and one participant dropped out of the placebo group due to drink taste. The remaining participants self-reported adherence to thrice daily drink consumption which was generally high at >70% across all weeks of the study. Remote data collection was largely feasible. Acceptability and general health questionnaires showed no obvious differences between groups. Overall, 90 days of exogenous ketone supplementation showed mixed feasibility. High drop-out due to gastrointestinal issues in the ketone group suggests that an alternative supplement formulation would likely be needed for future long-term adherence. However, participants who remained in the trial did show good compliance.

Text

2024-12-20

Attribution-NonCommercial-NoDerivatives 4.0 International

http://hdl.handle.net/2429/89960

Health and Exercise Sciences

University of British Columbia

UBCO

http://creativecommons.org/licenses/by-nc-nd/4.0/