Whey Protein Supplementation in Patients With Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Dietary Supplement: Fortiral; Dietary Supplement: Mg++

• Registration Number: NCT05523791
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-30
• Last Update Submitted: 2022-08-30
• Study First Posted: 2022-08-31
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WPS	Fortiral	Patients continued their standard therapy, received a standard protein redistribution dietary regimen plus a whey protein-based oral formula twice a day
Mg	Mg++	Patients continued their standard therapy, received a standard protein redistribution dietary regimen plus 2.250g of magnesium pidolate twice a day

Primary Outcome Measures

Name	Time	Method
Assessment of maintained efficacy of dopaminergic therapy in WPS group	4 weeks	Comparison of the deltas (T1-T0) of motor improvement (measured by UPDRS III; TUG, 6MWT) and of therapy (levodopa and LED) between the two groups.; Eventual impact of whey protein supplementation intake would lead to lower improvement in motor scales and/or need higher dopaminergic replacement therapy doses,

Trial Locations

Locations (1)

Ospedale Generale di Zona Moriggia Pelascini; 🇮🇹 Gravedona, Como, Italy