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Effect of Ketone Esters in Parkinson's Disease

Primary Purpose

Parkinson Disease, Ketosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketone Ester Elite endurance Nutrition Drink
Stool Sample
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring parkinson disease, ketosis, microbiota

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Women who are pregnant will be withdrawn from the study at that time.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.

Sites / Locations

  • Fixel Institute for Neurological Diseases

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ketone Intervention

Arm Description

Subjects will take the Ketone Ester Elite Endurance Nutrition Drink. They will drink 1 bottle 4 times daily for 4 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 22, 2020
Last Updated
January 3, 2022
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04477161
Brief Title
Effect of Ketone Esters in Parkinson's Disease
Official Title
Effect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
November 5, 2020 (Actual)
Study Completion Date
November 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Ketosis
Keywords
parkinson disease, ketosis, microbiota

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
pilot, prospective, single-arm, single-center study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketone Intervention
Arm Type
Experimental
Arm Description
Subjects will take the Ketone Ester Elite Endurance Nutrition Drink. They will drink 1 bottle 4 times daily for 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone Ester Elite endurance Nutrition Drink
Intervention Description
Subjects will take one bottle four times daily for four weeks
Intervention Type
Other
Intervention Name(s)
Stool Sample
Intervention Description
Subjects will provide a stool sample at 2 timepoints.
Primary Outcome Measure Information:
Title
Changes in serum Ketones
Description
by measuring the beta-hydroxybutyrate/serum glucose levels in blood at baseline and four months
Time Frame
Baseline up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Fixel Institute for Neurological Diseases
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Effect of Ketone Esters in Parkinson's Disease

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