Trial record 5 of 17 for:    LCIG

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2014 by Sheba Medical Center
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Dr. Oren Cohen, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT02274324
First received: October 22, 2014
Last updated: October 23, 2014
Last verified: October 2014
  Purpose
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.

Condition Intervention
Parkinson Disease
Dietary Supplement: different diets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • quality of life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    CGI, PDQ-39

  • dyskinesias [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    AIMS


Secondary Outcome Measures:
  • fluctuations [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    questioners regarding "off" time

  • motor function [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    UPDRS


Estimated Enrollment: 20
Study Start Date: October 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PD patients- Diet B first
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.
Dietary Supplement: different diets
3 different diets: A\B\C
Active Comparator: PD patients- Diet C first
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.
Dietary Supplement: different diets
3 different diets: A\B\C

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).

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02274324

Contacts
Contact: Esther Stein, B.Sc +972-3-5304931 Esther.Stein@sheba.health.gov.il
Contact: Yafit Ben-Mordechai, B.Sc +972-54-9919219 yafit@nutracoach.co.il

Sponsors and Collaborators
Sheba Medical Center
Tel Aviv University
Investigators
Study Director: Sharon Hassin, Dr Sheba Medical Center Israel
Principal Investigator: Oren Cohen, Dr Sheba Medical Center Israel
  More Information

Responsible Party: Dr. Oren Cohen, Dr, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02274324     History of Changes
Other Study ID Numbers: 1310-14-SMC 
Study First Received: October 22, 2014
Last Updated: October 23, 2014
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Sheba Medical Center:
parkinson
duodopa
diet
proteins
amino acids

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 28, 2016