Objective: To investigate the safety and tolerability of a high-dose exogenous ketone supplement in people with Parkinson’s Disease (PD).

Background: Animal models and small pilot studies suggest that exogenous ketone supplementation may be beneficial for symptoms of PD, but the safety and efficacy of these products has not been evaluated.

Method: Participants with PD were recruited for this 4-week prospective pilot study. Participants were instructed to consume 25g of liquid D-betahydroxybutyrate (BHB) 4 times daily for 4 weeks. On days 1 and 29, blood glucose and ketone concentrations were measured using a handheld blood glucometer and ketometer before and after ingesting of 25g BHB while having fasted overnight. Blood levels were measured prior to, 2 hours post, and 4 hours post ketone ester consumption. Body weight was collected, and nutrition status was assessed by a dietitian using the Patient-Generated Subjective Global Assessment (PG-SGA). Body weights and PG-SGA total scores were compared with a paired t-test. Participants were also contacted weekly to assess tolerability and side effects.

Results: 10 participants were enrolled in the study but complete data was available in 8 patients for both the day 1 and 29 assessments. All participants had a low or undetectable concentration of blood ketones before drinking the supplement. Blood ketone levels (mean± SD) increased to 2.3± 0.8mM (n=10; day 1) and 1.5± 0.8mM (n=8; day 29) 2-hours post-consumption. At 4 hours post ingestion, blood ketone levels approached pre-ingestion levels (0.6± 0.6mM on day 1; 0.9± 1.1mM on day 29). Blood glucose levels remained within normal limits during the 4-hour monitoring period for both visits. No significant changes in body weight were found (p=0.162). Mean total PG-SGA scores were not statistically different between visits (p=0.632), and no participants were found to be at significant nutrition risk at either visit. On the weekly follow-up calls, participants most often reported experiencing intermittent nausea, reflux, and general anorexia. A single participant withdrew from the study after 1 week due to severe nausea. A second participant was unable to attend the day 29 visit due to concerns related to the coronavirus pandemic.

Conclusion: These results may indicate that exogenous ketone supplements are safe for consumption in the PD population. Further studies are needed to explore changes in blood ketone concentrations and long-term tolerability.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/safety-and-tolerability-of-a-ketone-supplement-in-parkinsons-disease/