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

Sheba Medical Center

Status: Unknown

Conditions: Parkinson Disease

Treatments: Dietary Supplement: different diets

Study type: Interventional

Funder types: Other

Identifiers

NCT02274324

1310-14-SMC

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

PD patients- Diet B first

Active Comparator group

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.

Treatment:

Dietary Supplement: different diets

PD patients- Diet C first

Active Comparator group

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.

Treatment:

Dietary Supplement: different diets