Skip to content

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

Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02274324
Enrollment
20
Registered
2014-10-24
Start date
2014-10-31
Completion date
2017-12-31
Last updated
2014-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

parkinson, duodopa, diet, proteins, amino acids

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).

Interventions

DIETARY_SUPPLEMENTdifferent diets

3 different diets: A\\B\\C

Sponsors

Tel Aviv University
CollaboratorOTHER
Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
quality of life4 monthsCGI, PDQ-39
dyskinesias4 monthsAIMS

Secondary

MeasureTime frameDescription
fluctuations4 monthsquestioners regarding off time
motor function4 monthsUPDRS

Contacts

Primary ContactEsther Stein, B.Sc
Esther.Stein@sheba.health.gov.il+972-3-5304931
Backup ContactYafit Ben-Mordechai, B.Sc
yafit@nutracoach.co.il+972-54-9919219

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026