Status:
COMPLETED
Effect of Ketone Esters in Parkinson's Disease
Lead Sponsor:
University of Florida
Conditions:
Parkinson Disease
Ketosis
Eligibility:
All Genders
40-75 years
Phase:
NA
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 i...
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...
Eligibility Criteria
Inclusion
- 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
- 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 Women who are pregnant will be withdrawn from the study at that time.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.
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04477161
Start Date
September 5 2019
End Date
November 5 2020
Last Update
January 4 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fixel Institute for Neurological Diseases
Gainesville, Florida, United States, 32608