Effect of Ketone Esters in Parkinson's Disease

NCT04477161 | Completed

• 3 other identifiers: Ketone in PDIRB201901326OCR24402
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Ketosis

Keywords

parkinson disease; ketosis; microbiota

Outcome Measures

Primary Outcomes (1)

• Changes in serum Ketones

  by measuring the beta-hydroxybutyrate/serum glucose levels in blood at baseline and four months

  Baseline up to 4 months

Study Arms (1)

Ketone Intervention

EXPERIMENTAL

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; Other: Stool Sample

Interventions

Ketone Ester Elite endurance Nutrition Drink DIETARY_SUPPLEMENT

Subjects will take one bottle four times daily for four weeks

Ketone Intervention

Stool Sample OTHER

Subjects will provide a stool sample at 2 timepoints.

Ketone Intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician-diagnosed Parkinson's Disease
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Ketosis

Condition Hierarchy (Ancestors)

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; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pilot, prospective, single-arm, single-center study

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 20, 2020
• Study Start: September 5, 2019
• Primary Completion: November 5, 2020
• Study Completion: November 5, 2020
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)