Effect of Ketone Esters in Parkinson's Disease
Condition: Parkinson Disease; Ketosis
MeSH terms: Parkinson Disease; Ketosis
Study type: Interventional

Summary: 
      Ketones esters have shown to improve mitochondrial function and are currently use to enhanced
      functional performance. As Mitochondrial dysfunction is one of the proposed mechanism of
      neuronal injury in Parkinson's disease, the study aims to assess the tolerability,side
      effects and effect of oral ketone esters in Patients with Parkinson's disease.
    

Detailed description: 
      Parkinson's Disease (PD) is a debilitating progressive neurodegenerative disorder, second in
      frequency only to Alzheimer's disease, affecting around 10 million people worldwide. PD is
      characterized by loss of dopaminergic cells in substantia nigra and the accumulation of Lewy
      bodies. There is no disease modifying treatment or cure for the disease and management
      strategies focus on symptomatic treatment. One of the proposed mechanisms for the
      dopaminergic neurons degeneration in sporadic Parkinson's disease cases is related to
      compromise cellular bioenergetics, resulting in excessive production of reactive oxygen
      species (ROS) that leads to oxidative stress. Numerous studies have identified mitochondrial
      dysfunction as the central pathological features of both genetic and sporadic PD.
      Mitochondrial dysfunction can also increase inflammation which is associated with PD and Lewy
      Body formation. Elevated plasma ketones have been shown to enhance energy reserves, ATP
      levels and the expression of many enzymes involved in multiple metabolic pathways in the
      mitochondria. This pilot study aims to assess the effect of an exogenous ketone supplement on
      functional performance in people with PD. Changes in inflammatory makers will also be
      assessed. Participants will ingest the exogenous ketone supplement four times per day for
      four weeks. Participants will undergo neurological, functional, and cognitive assessments
      prior to and after the four-week intervention. Dietitians will follow up with participants
      weekly for compliance and counseling. Diet will be assessed throughout the study using the
      automated self-administered 24-hour dietary recall. After the four week intervention, a
      two-week "washout" period will be observed before reassessing functional and cognitive
      performance again.

      Additionally, the study would like to establish the extent to which the use of Ketone esters
      impact the gut microbiota. Gut microbita composition in PD has been associated with symptoms
      and treatment efficacy.
    

Intervention name(s): Ketone Ester Elite endurance Nutrition Drink; Stool Sample
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Subjects will take one bottle four times daily for four weeks; Subjects will provide a stool sample at 2 timepoints.
Intervention model: Single Group Assignment
Intervention model description: pilot, prospective, single-arm, single-center study
Masking: None (Open Label)
Primary purpose: Other
Keywords: parkinson disease; ketosis; microbiota