Whey Protein Supplementation in Patients With Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Can we Add Whey Protein Supplementation in Patients With Parkinson's Disease Without Interfering With Levodopa Response?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05523791
• Other study ID #: 4803
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Dietary Supplement:
• Fortiral
Twice a day, patients took 10 g of powder containing 92.5% whey protein with 2.7% cysteine; emulsifier: soy lecithin, lactose free to be reconstituted with 150-200 ml of water.
• Mg++
Twice a day, patients took 2.250g of magnesium pidolate (=184 mg of Magnesium++ ione) powder twice a day to be reconstituted with 150-200 ml of water

Locations

Country	Name	City	State
Italy	Ospedale Generale di Zona Moriggia Pelascini	Gravedona	Como

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of maintained efficacy of dopaminergic therapy in WPS group	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,	4 weeks