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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
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 8, 2016
Last Updated
February 16, 2016
Sponsor
University of Padova
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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
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Effect of a Lipidic and Proteic Controlled Diet on Parkinson's Disease

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