ClinicalTrials.gg
CompletedNCT05523791Updated Aug 31, 2022

Whey Protein Supplementation in Patients With Parkinson's Disease

An interventional study of Fortiral and Mg++ in Parkinson Disease, sponsored by Ospedale Generale Di Zona Moriggia-Pelascini. Completed at 1 site in Italy. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-08-31.

Sponsored by Ospedale Generale Di Zona Moriggia-Pelascini · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jan 2022, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini — none open to participants now, none under way, none of them phase 3. Parkinson Disease · Ospedale Generale Di Zona Moriggia-Pelascini.

Enrollment
10th of 13
51 · median 100
Started
2022
the only one that year
No phase
13 of 23
none open now
Registered
23rd of 23
by date

Among the 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini, this one is the 10th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2022, is one of 13 with no phase, and was the 23rd registered.

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

Browse Parkinson Disease studies →

Open to participants now

None of the 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini is open now. The open studies under Parkinson Disease, anywhere →

Where they have run

Who these studies take

Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.

This study: 60 Years and older · all sexes · no healthy volunteers.

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Download CSVNarrow it in search →With an account: the 23 studies in Parkinson Disease by Ospedale Generale Di Zona Moriggia-Pelascini as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Parkinson Disease

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Keywords

  • levodopa
  • whey protein supplementation
  • aerobic rehabilitation
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • cognitive decline
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
51 participants (actual)

Study arms

  • Experimental
    WPS

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

    Dietary Supplement: Fortiral

  • Active comparator
    Mg

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

    Dietary Supplement: Mg++

Interventions

  • Dietary supplementFortiral

    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.

  • Dietary supplementMg++

    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

06

What researchers measure

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,

    Time frame: 4 weeks

07

Study locations

1 site
  • Ospedale Generale di Zona Moriggia Pelascini
    Gravedona, Como 22015, Italy
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2022 to primary completion in Jun 2022, 5 months.

Of 1,291 non-industry interventional studies with no phase under Parkinson Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's 5 months is below that.

Counting every sponsor, half of 1,367 studies reached it within 25 months; a quarter within 11 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 17, 2022
First posted
Aug 31, 2022
StartActual
Jan 1, 2022
Primary completionActual
Jun 30, 2022
CompletionActual
Jun 30, 2022
Last update
Aug 31, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05523791
Lead sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Responsible party
Sponsor
First posted
Aug 31, 2022
Start date
Jan 1, 2022
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022
Last update
Aug 31, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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