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Whey Protein Supplementation in Patients With Parkinson's Disease

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Fortiral

Mg++

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring levodopa, whey protein supplementation, aerobic rehabilitation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Ospedale Generale di Zona Moriggia Pelascini

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WPS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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,

Secondary Outcome Measures

Full Information

NCT ID

NCT05523791

First Posted

August 17, 2022

Last Updated

August 30, 2022

Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

1. Study Identification

Unique Protocol Identification Number

NCT05523791

Brief Title

Whey Protein Supplementation in Patients With Parkinson's Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

January 1, 2022 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

levodopa, whey protein supplementation, aerobic rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

WPS

Arm Type

Experimental

Arm Description

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

Arm Title

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Fortiral

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Mg++

Intervention Description

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

Primary Outcome Measure Information:

Title

Assessment of maintained efficacy of dopaminergic therapy in WPS group

Description

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Ospedale Generale di Zona Moriggia Pelascini

City

Gravedona

State/Province

Como

ZIP/Postal Code

22015

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Whey Protein Supplementation in Patients With Parkinson's Disease

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