- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05523791
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?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Como
-
Gravedona, Como, Italy, 22015
- Ospedale Generale di Zona Moriggia Pelascini
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WPS
Patients continued their standard therapy, received a standard protein redistribution dietary regimen plus a whey protein-based oral formula twice a day
|
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.
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Active Comparator: Mg
Patients continued their standard therapy, received a standard protein redistribution dietary regimen plus 2.250g of magnesium pidolate twice a day
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of maintained efficacy of dopaminergic therapy in WPS group
Time Frame: 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, |
4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4803
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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