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Ketone Ester

Healthy Controls for Parkinson's Disease

N/A

Waitlist Available

Led By Nicolaas Bohnen, MD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after approximately 30 days of intervention

Awards & highlights

Study Summary

This trial studied using a ketone supplement to help people with Parkinson's, Parkinson's dementia, and healthy people.

Eligible Conditions

Parkinson's Disease
Dementia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after approximately 30 days of intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after approximately 30 days of intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and after approximately 30 days of intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Average Glucose metabolism

Clinical Dementia Rating scale score

Fluorodeoxyglucose (FDG) positron emission tomography (PET) brain

Secondary outcome measures

Average gait speed

Change in Benton Judgement of Line Orientation scores

Change in scores on the Boston Naming Test

+16 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Parkinson Disease Dementia/Lewy Body DementiaExperimental Treatment1 Intervention

Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary.

Group II: Parkinson DiseaseExperimental Treatment1 Intervention

Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary.

Group III: Healthy ControlsExperimental Treatment1 Intervention

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Who is running the clinical trial?

University of MichiganLead Sponsor

1,794 Previous Clinical Trials

6,373,900 Total Patients Enrolled

Farmer Family FoundationUNKNOWN

Nicolaas Bohnen, MDPrincipal InvestigatorUniversity of Michigan

2 Previous Clinical Trials

26 Total Patients Enrolled

Media Library

(R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate (Ketone Ester) Clinical Trial Eligibility Overview. Trial Name: NCT05778695 — N/A

Parkinson's Disease Research Study Groups: Healthy Controls, Parkinson Disease, Parkinson Disease Dementia/Lewy Body Dementia

Parkinson's Disease Clinical Trial 2023: (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate Highlights & Side Effects. Trial Name: NCT05778695 — N/A

(R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate (Ketone Ester) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05778695 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How detrimental can Parkinson Disease be for individuals?

"Due to the limited data available, our team at Power has assigned a score of 1 in terms of safety for this Phase 1 trial related to Parkinson disease."

Answered by AI

Are new participants being recruited for this clinical research currently?

"According to information on clinicaltrials.gov, this medical experiment is not presently enrolling patients. It was first announced on March 1st 2023 and the last update was made 9 days later. Despite that, there are 882 other studies actively recruiting participants at present."

Answered by AI

What results are anticipated from this clinical research?

"The primary objective of this 30-day trial is to assess the Fluorodeoxyglucose (FDG) positron emission tomography (PET) brain. Secondary assessments include the Montreal Cognitive Assessment (MoCA), which gauges mild cognitive impairment and scores between 0-30, with a higher score representing enhanced performance; an Instrumented Timed Up and Go test (iTUG), measuring mobility through time taken to stand up, walk 10 feet, turn around, walk back and sit down in seconds; as well as Mini Balance Evaluation Systems test (Mini-BESTest). This scale evaluates balance control systems ranging from 1"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones

Nicolaas Bohnen, MD, PhD 2023. "Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05778695.