Clinical trial NCT04477161: Effect of Ketone Esters in Parkinson's Disease
Official title: Effect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Ketosis
Keywords: parkinson disease
ketosis
microbiota
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 10
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pilot, prospective, single-arm, single-center study
Primary purpose: OTHER

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in serum Ketones
timeFrame: Baseline up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Fixel Institute for Neurological Diseases
state: Florida
Study officials:
References: