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

NCT ID: NCT02274324

Last Updated: 2014-10-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-12-31

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).

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

different diets

Intervention Type: DIETARY_SUPPLEMENT

3 different diets: A\\B\\C

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.

Group Type: ACTIVE_COMPARATOR

different diets

Intervention Type: DIETARY_SUPPLEMENT

3 different diets: A\\B\\C

Interventions

different diets

3 different diets: A\\B\\C

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tel Aviv University

OTHER

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Oren Cohen

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sharon Hassin, Dr

Role: STUDY_DIRECTOR

Sheba Medical Center

Oren Cohen, Dr

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Central Contacts

Esther Stein, B.Sc

Role: CONTACT

Esther.Stein@sheba.health.gov.il

+972-3-5304931

Yafit Ben-Mordechai, B.Sc

Role: CONTACT

yafit@nutracoach.co.il

+972-54-9919219

Other Identifiers

1310-14-SMC

Identifier Type: -

Identifier Source: org_study_id