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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02687698
• Other study ID #: 3575/AO/15
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 8, 2016
• Last updated: February 16, 2016
• Start date: February 2016
• Est. completion date: February 2017

Study information

• Verified date: February 2016
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Ketogenic diet
The proposed ketogenic diet will concern a low glucidic diet with 60-70% of lipidic intake and 20-30% of proteins.

Locations

Country	Name	City	State
Italy	Geriatric Section	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Vanitallie TB, Nonas C, Di Rocco A, Boyar K, Hyams K, Heymsfield SB. Treatment of Parkinson disease with diet-induced hyperketonemia: a feasibility study. Neurology. 2005 Feb 22;64(4):728-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in resting energy expenditure	Changes in resting energy expenditure as measured by indirect calorimetry	Baseline, week 4 and week 8	No