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Dietary Intervention

Ketogenic Diet for Parkinson's Disease (KIM Trial)

N/A

Waitlist Available

Led By Silke Appel-Cresswell, MD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

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

Must have

Hoehn & Yahr score of 1 to 3

Age between 40-85 years

Must not have

Atypical parkinsonism

Inflammatory bowel disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up preintervention 1 (baseline 1)/ post-intervention 1 (week 8)/ pre-intervention 2 (baseline 2; week 16)/ post-intervention 2 (week 24)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to study a modified Mediterranean-ketogenic diet to see if it is safe for patients with Parkinson's Disease and does not disrupt the balance of microorganisms in the gut."

Who is the study for?

This trial is for people aged 40-85 with Parkinson's Disease, who have a mild to moderate severity score (Hoehn & Yahr score of 1 to 3) and are on stable medication. It's not suitable for those outside this age range or disease severity, or whose treatment isn't consistent.

What is being tested?

The study tests if a Mediterranean diet with added medium-chain triglyceride oil can be beneficial in Parkinson’s without disrupting the gut microbiome, compared to a standard Mediterranean-Ketogenic Diet.

What are the potential side effects?

Potential side effects aren't specified but may include changes in digestion due to dietary adjustments. The focus is on safeguarding gut health while assessing benefits for Parkinson’s symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Parkinson's disease is mild to moderately severe.

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I am between 40 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a rare form of Parkinson's disease.

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I have inflammatory bowel disease.

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I have severe difficulty swallowing.

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I am taking warfarin for blood thinning.

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I manage my diabetes with insulin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ preintervention 1 (baseline 1)/ post-intervention 1 (week 8)/ pre-intervention 2 (baseline 2; week 16)/ post-intervention 2 (week 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~preintervention 1 (baseline 1)/ post-intervention 1 (week 8)/ pre-intervention 2 (baseline 2; week 16)/ post-intervention 2 (week 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and preintervention 1 (baseline 1)/ post-intervention 1 (week 8)/ pre-intervention 2 (baseline 2; week 16)/ post-intervention 2 (week 24) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline and difference across interventions in measures of fecal and serum calprotectin, a biomarker for gut inflammation.

Changes from baseline and differences across interventions in other measures of gut health, namely short-chain fatty acid production, gut-barrier integrity, and microbial composition.

Secondary study objectives

Percent time spent in clinically relevant levels of ketosis ( equivalent to >0.5 mmol/L) by each participant throughout each intervention.

The number of participants who completed the study after successful enrollment relative to the total enrolled participants.

Other study objectives

Assessing changes in capacity for performing physical activities in the study participants after each intervention

Interventional procedure

Assessing the constipation and irritable bowl symptoms in the study participants

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