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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
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring parkinson, duodopa, diet, proteins, amino acids

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 22, 2014
    Last Updated
    October 23, 2014
    Sponsor
    Sheba Medical Center
    Collaborators
    Tel Aviv University
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    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

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    Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease

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