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

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Other: Ketogenic diet

• Registration Number: NCT02687698
• Lead Sponsor: University of Padova

Brief Summary

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

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.

Study Timeline

• Status Verified: 2016-02
• Study Start: 2016-02
• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-16
• Last Update Submitted: 2016-02-16
• Study First Posted: 2016-02-22
• Last Update Posted: 2016-02-22
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketogenic diet	Ketogenic diet	Patients will be suggested to follow a ketogenic diet for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in resting energy expenditure	Baseline, week 4 and week 8	Changes in resting energy expenditure as measured by indirect calorimetry

Trial Locations

Locations (1)

Geriatric Section; 🇮🇹 Padova, Italy