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Whey Protein Supplementation in Patients With Parkinson's Disease

NCT ID: NCT05523791

Last Updated: 2022-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-06-30

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Keywords

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levodopa whey protein supplementation aerobic rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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WPS

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

Group Type EXPERIMENTAL

Fortiral

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

Mg++

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ospedale Generale di Zona Moriggia Pelascini

Gravedona, Como, Italy

Site Status

Countries

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Italy

Other Identifiers

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4803

Identifier Type: -

Identifier Source: org_study_id