Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
different diets
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring parkinson, duodopa, diet, proteins, amino acids
Eligibility Criteria
Inclusion Criteria:
- Patients treated with Duodopa at least three months and are stable on medical therapy
- Patients should be not demented, able to fill diaries and to sign an informed consent
Exclusion Criteria:
- Severe dementia
- Inability to fill out diaries
- Unstable mediated condition
- Chronic renal failure
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PD patients- Diet B first
PD patients- Diet C first
Arm Description
Patients treated with Duodopa at least three months and are stable on medical therapy. The intervention cosists of Dietary Change. Patients that will be randomized to this group will start diet B and then crossover to diet C.
Patients treated with Duodopa at least three months and are stable on medical therapy. The intervention cosists of Dietary Change. Patients that will be randomized to this group will start diet C and then crossover to diet B.
Outcomes
Primary Outcome Measures
quality of life
CGI, PDQ-39
dyskinesias
AIMS
Secondary Outcome Measures
fluctuations
questioners regarding "off" time
motor function
UPDRS
Full Information
NCT ID
NCT02274324
First Posted
October 22, 2014
Last Updated
October 23, 2014
Sponsor
Sheba Medical Center
Collaborators
Tel Aviv University
1. Study Identification
Unique Protocol Identification Number
NCT02274324
Brief Title
Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease
Official Title
Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
Collaborators
Tel Aviv University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the role of dietary modifications of 3 different diets on clinical outcomes in patients with PD treated with Duodopa®. This is in search for an optimal diet that will accompany Duodopa® treatment and will optimize effect on fluctuations and dyskinesias and thus improve motor function and quality of life.
Detailed Description
A prospective single-blind-crossover study in patients with PD regularly treated with Duodopa® (LICG) in which three different diets will be given. Diet A: Low fat western diet - traditional low-fat Western diet; a normal diet according to the recommendations of health organizations in which proteins consumed throughout the day, high-protein meal at noon and in the evening.
Diet B: Equal protein redistribution diet (EPRD) - proteins consumption is controlled and equally distributed over six meals throughout the day to minimize motor fluctuations.
Diet C: Protein redistribution diet (PRD) in which proteins are consumed in the morning prior to connection to the pump and in the evening after disconnecting from the . Carbohydrates and fats will be consumed during the day.
Following recruitment and study initiation patients will consume diet A for 3 weeks. Patients will then be randomized into either diet B or diet C for 3 additional weeks. At completion of this period patients will consume diet A for 2 weeks ("wash-out" period) and will then be "crosseovered" to get the third diet (B or C).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
parkinson, duodopa, diet, proteins, amino acids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PD patients- Diet B first
Arm Type
Active Comparator
Arm Description
Patients treated with Duodopa at least three months and are stable on medical therapy. The intervention cosists of Dietary Change. Patients that will be randomized to this group will start diet B and then crossover to diet C.
Arm Title
PD patients- Diet C first
Arm Type
Active Comparator
Arm Description
Patients treated with Duodopa at least three months and are stable on medical therapy. The intervention cosists of Dietary Change. Patients that will be randomized to this group will start diet C and then crossover to diet B.
Intervention Type
Dietary Supplement
Intervention Name(s)
different diets
Intervention Description
3 different diets: A\B\C
Primary Outcome Measure Information:
Title
quality of life
Description
CGI, PDQ-39
Time Frame
4 months
Title
dyskinesias
Description
AIMS
Time Frame
4 months
Secondary Outcome Measure Information:
Title
fluctuations
Description
questioners regarding "off" time
Time Frame
4 months
Title
motor function
Description
UPDRS
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients treated with Duodopa at least three months and are stable on medical therapy
Patients should be not demented, able to fill diaries and to sign an informed consent
Exclusion Criteria:
Severe dementia
Inability to fill out diaries
Unstable mediated condition
Chronic renal failure
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Stein, B.Sc
Phone
+972-3-5304931
Email
Esther.Stein@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yafit Ben-Mordechai, B.Sc
Phone
+972-54-9919219
Email
yafit@nutracoach.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Hassin, Dr
Organizational Affiliation
Sheba Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Oren Cohen, Dr
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease
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