Effect of a Lipidic and Proteic Controlled Diet on Parkinson's Disease

Study Overview
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Brief Summary
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Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in patients with Parkinson's disease.

Detailed Description
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Parkinson's disease concerns some defects in carbohydrates metabolism involved in the progress of the pathology. Ketogenic diet has been largely studied as treatment on drug-resistant epilepsy and other neurologic diseases, but there is little information on the impact of this kind of diet in clinical aspects of Parkinson's disease. The aim of our study is thus to evaluate the effect of a lipid and protein controlled diet on resting energy expenditure, body composition and symptoms in Parkinson's disease patients.

Official Title
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Effect of a Lipidic and Proteic Controlled Diet on Resting Energy Expenditure, Body Composition and Symptoms in Patients With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Ketogenic diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with a diagnosis of Parkinson's disease, treated with L-Dopa or other dopaminergic drugs. Mini Mental State Examination (MMSE) >24. Activities of Daily Living >3. Exclusion Criteria: Mini nutritional assessment <17; BMI <18, hypoalbuminemia or lymphopenia. acute or chronic liver diseases; renal function impairment (Clearance creatinine <30ml/min); cancer; acute inflammatory diseases; thyroid diseases; diabetes mellitus; dysphagia; dementia; dyslipidemia; history of recent cardiovascular or cerebrovascular events; psychiatric diseases; iatrogen parkinsonism.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketogenic diet<br>Patients will be suggested to follow a ketogenic diet for 8 weeks. | Other: Ketogenic diet<br>* The proposed ketogenic diet will concern a low glucidic diet with 60-70% of lipidic intake and 20-30% of proteins.<br>|
| No Intervention: Control<br>Usual diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in resting energy expenditure | Changes in resting energy expenditure as measured by indirect calorimetry | Baseline, week 4 and week 8 |