Whey Protein Supplementation in Patients With Parkinson's Disease

Ospedale Generale Di Zona Moriggia-Pelascini

Status: Completed

Conditions: Parkinson Disease

Treatments: Dietary Supplement: Mg++; Dietary Supplement: Fortiral

Study type: Interventional

Funder types: Other

Identifiers

NCT05523791

4803

Details and patient eligibility

About

Many dietary supplementations are available to help people in balancing the protein intake and overcoming muscle mass loss. However, most of the products contain protein and could potentially affect levodopa action in people with Parkinson's disease (PWPD). The study aims at verify if whey protein supplementation interferes with dopamine replacement therapy efficacy in PWPD admitted at the clinic for a four weeks intensive multidisciplinary rehabilitation training.

Full description

Authors performed a randomised single blind monocentric study on PWPD admitted in the rehabilitative unit of the Moriggia Pelascini Hospital for a 4-week multidisciplinary intensive aerobic rehabilitation treatment. All patients received a standard protein redistribution dietary regimen plus a whey protein-based oral formula (N=26) or Magnesium (N=25) twice daily for 28 days.

Neurological assessment and physical evaluation were conducted before (T0) and after (T1) rehabilitative treatment; dopamine replacement therapy was recorded T0 and T1 as well. The delta of changes within groups in neurological (UPDRS III) and physical (TUG, 6MW) evaluation scales was compared between groups.

Enrollment: 51 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of Parkinson's disease (UKBB criteria Hughes et al., 1992),
• H&Y stage 2 or 3
• presence of motor fluctuations (by means of UPDRS III item 4.3≥1)

Exclusion criteria

• cognitive decline

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 2 patient groups

WPS

Experimental group

Description:

Patients continued their standard therapy, received a standard protein redistribution dietary regimen plus a whey protein-based oral formula twice a day

Treatment:

Dietary Supplement: Fortiral

Mg

Active Comparator group

Description:

Patients continued their standard therapy, received a standard protein redistribution dietary regimen plus 2.250g of magnesium pidolate twice a day

Treatment:

Dietary Supplement: Mg++