Effect of Ketone Esters in Parkinson's Disease

Status Completed

Clinical Trial 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04477161
Study type	Interventional
Source	University of Florida
Contact
Status	Completed
Phase	N/A
Start date	September 5, 2019
Completion date	November 5, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05415774` - Combined Deep Brain Stimulation in Parkinson's Disease	N/A
Recruiting	`NCT04691661` - Safety, Tolerability, Pharmacokinetics and Efficacy Study of Radotinib in Parkinson's Disease	Phase 2
Active, not recruiting	`NCT05754086` - A Multidimensional Study on Articulation Deficits in Parkinsons Disease
Completed	`NCT04045925` - Feasibility Study of the Taïso Practice in Parkinson's Disease	N/A
Recruiting	`NCT04194762` - PARK-FIT. Treadmill vs Cycling in Parkinson´s Disease. Definition of the Most Effective Model in Gait Reeducation	N/A
Completed	`NCT02705755` - TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)	Phase 2
Terminated	`NCT03052712` - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies	N/A
Recruiting	`NCT05830253` - Free-living Monitoring of Parkinson's Disease Using Smart Objects
Recruiting	`NCT03272230` - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System	N/A
Recruiting	`NCT06139965` - Validity and Reliability of the Turkish Version of the Comprehensive Coordination Scale in Parkinson's Patients
Completed	`NCT04580849` - Telerehabilitation Using a Dance Intervention in People With Parkinson's Disease	N/A
Completed	`NCT03980418` - Evaluation of a Semiconductor Camera for the DaTSCAN™ Exam	N/A
Recruiting	`NCT04788693` - Effects of Gait Rehabilitation With Motor Imagery in People With Parkinson's Disease	N/A
Completed	`NCT04942392` - Digital Dance for People With Parkinson's Disease During the COVID-19 Pandemic	N/A
Terminated	`NCT03446833` - LFP Beta aDBS Feasibility Study	N/A
Completed	`NCT03497884` - Individualized Precise Localization of rTMS on Primary Motor Area	N/A
Completed	`NCT05538455` - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases	N/A
Recruiting	`NCT04997642` - Parkinson's Disease and Movement Disorders Clinical Database
Completed	`NCT04117737` - A Pilot Study of Virtual Reality and Antigravity Treadmill for Gait Improvement in Parkinson	N/A
Recruiting	`NCT03618901` - Rock Steady Boxing vs. Sensory Attention Focused Exercise	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.