Effect of a Lipidic and Proteic Controlled Diet on Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ketogenic diet
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
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.
Sites / Locations
- Geriatric Section
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Ketogenic diet
Control
Arm Description
Patients will be suggested to follow a ketogenic diet for 8 weeks.
Usual diet.
Outcomes
Primary Outcome Measures
Changes in resting energy expenditure
Changes in resting energy expenditure as measured by indirect calorimetry
Secondary Outcome Measures
Full Information
NCT ID
NCT02687698
First Posted
February 8, 2016
Last Updated
February 16, 2016
Sponsor
University of Padova
1. Study Identification
Unique Protocol Identification Number
NCT02687698
Brief Title
Effect of a Lipidic and Proteic Controlled Diet on Parkinson's Disease
Official Title
Effect of a Lipidic and Proteic Controlled Diet on Resting Energy Expenditure, Body Composition and Symptoms in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ketogenic diet
Arm Type
Experimental
Arm Description
Patients will be suggested to follow a ketogenic diet for 8 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual diet.
Intervention Type
Other
Intervention Name(s)
Ketogenic diet
Intervention Description
The proposed ketogenic diet will concern a low glucidic diet with 60-70% of lipidic intake and 20-30% of proteins.
Primary Outcome Measure Information:
Title
Changes in resting energy expenditure
Description
Changes in resting energy expenditure as measured by indirect calorimetry
Time Frame
Baseline, week 4 and week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caterina Trevisan, MD
Organizational Affiliation
University of Padova, Geriatric Section
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric Section
City
Padova
ZIP/Postal Code
35128
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
15728303
Citation
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. doi: 10.1212/01.WNL.0000152046.11390.45.
Results Reference
result
Learn more about this trial
Effect of a Lipidic and Proteic Controlled Diet on Parkinson's Disease
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