Effect of Ketone Esters in Parkinson's Disease

Effect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Ketosis
• Intervention / Treatment: Dietary supplement: Ketone Ester Elite endurance Nutrition Drink; Other: Stool Sample

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Fixel Institute for Neurological Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Physician-diagnosed Parkinson's Disease
• 40-75 years of age
• On stable dopaminergic therapy
• Willing and able to complete the informed consent form in English
• Willing to consume the study supplement four times each day during the 4-week intervention period
• Willing to complete all dietary recalls over approximately 6 weeks
• Willing to complete all daily and weekly questionnaires throughout the six weeks.

Exclusion Criteria:

• Does not meet the above criteria
• Atypical or secondary Parkinsonism
• BMI >30
• Rheumatological or other inflammatory conditions
• Following of the ketogenic diet
• History of ulcer disease
• History of irritable bowel disorder or irritable bowel syndrome
• Currently taking any medication that could affect stool formation.
• Diagnosis of Diabetes mellitus Type 1 or Type 2
• Currently smoking (including vaping) tobacco products.
• Women who are lactating, know that they are pregnant, or are attempting to get pregnant.
• Note: a pregnancy test will be administered prior to initiating consumption of the study supplement. Women who are pregnant will be withdrawn from the study at that time.
• Use of another investigational product within 3 months of the initial visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketone Intervention; Subjects will take the Ketone Ester Elite Endurance Nutrition Drink. They will drink 1 bottle 4 times daily for 4 weeks	Dietary supplement: Ketone Ester Elite endurance Nutrition Drink; Subjects will take one bottle four times daily for four weeks; Other: Stool Sample; Subjects will provide a stool sample at 2 timepoints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in serum Ketones	by measuring the beta-hydroxybutyrate/serum glucose levels in blood at baseline and four months	Baseline up to 4 months

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Actual): November 5, 2020
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: microbiota; ketosis; parkinson disease
• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Acid-Base Imbalance; Acidosis; Parkinson Disease; Ketosis
• Other Study ID Numbers: Ketone in PD; IRB201901326 (Other Identifier: UF IRB); OCR24402 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Participant data will be shared with collaborators on project here at the University of Florida and only de-identified data will be released with IRB approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No