Whey Protein Supplementation in Patients With Parkinson's Disease
Can we Add Whey Protein Supplementation in Patients With Parkinson's Disease Without Interfering With Levodopa Response?
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Jan 2022
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedFirst Submitted
Initial submission to the registry
August 17, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedAugust 31, 2022
August 1, 2022
6 months
August 17, 2022
August 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
WPS
EXPERIMENTALPatients continued their standard therapy, received a standard protein redistribution dietary regimen plus a whey protein-based oral formula twice a day
Mg
ACTIVE COMPARATORPatients continued their standard therapy, received a standard protein redistribution dietary regimen plus 2.250g of magnesium pidolate twice a day
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- cognitive decline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ospedale Generale di Zona Moriggia Pelascini
Gravedona, Como, 22015, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2022
First Posted
August 31, 2022
Study Start
January 1, 2022
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
August 31, 2022
Record last verified: 2022-08