Effect of Ketone Esters in Parkinson's Disease

• ClinicalTrials.gov Identifier: NCT04477161
• Recruitment Status: Completed
• First Posted: July 20, 2020
• Last Update Posted: January 4, 2022
• Sponsor: University of Florida
• Information provided by (Responsible Party): University of Florida

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease; Ketosis	Dietary Supplement: Ketone Ester Elite endurance Nutrition Drink; Other: Stool Sample	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: pilot, prospective, single-arm, single-center study
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.
• Actual Study Start Date: September 5, 2019
• Actual Primary Completion Date: November 5, 2020
• Actual Study Completion Date: November 5, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Changes in serum Ketones [ Time Frame: Baseline up to 4 months ]
   by measuring the beta-hydroxybutyrate/serum glucose levels in blood at baseline and four months

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Florida

Fixel Institute for Neurological Diseases

Gainesville, Florida, United States, 32608

Sponsors and Collaborators

University of Florida

More Information

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT04477161
• Other Study ID Numbers: Ketone in PD; IRB201901326 ( Other Identifier: UF IRB ); OCR24402 ( Other Identifier: UF OnCore )
• First Posted: July 20, 2020
• Last Update Posted: January 4, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:

parkinson disease; ketosis; microbiota

Additional relevant MeSH terms:

Parkinson Disease; Ketosis; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases