Parkinson DiseaseNCT05523791
Whey Protein Supplementation in Patients With Parkinson's Disease
A study testing Fortiral and Mg++ in people with Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Fortiral and Mg++
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- cognitive decline
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can we Add Whey Protein Supplementation in Patients With Parkinson's Disease Without Interfering With Levodopa Response?
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.
- Conditions
- Parkinson Disease
- Being tested
- Fortiral, Mg++
- Keywords
- levodopa, whey protein supplementation, aerobic rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FortiralDietary 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++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
| Study group | Role | What they receive |
|---|---|---|
| WPS | Experimental | Patients continued their standard therapy, received a standard protein redistribution dietary regimen plus a whey protein-based oral formula twice a day Receives: Dietary Supplement: Fortiral |
| Mg | Active comparator | Patients continued their standard therapy, received a standard protein redistribution dietary regimen plus 2.250g of magnesium pidolate twice a day Receives: Dietary Supplement: Mg++ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Jan 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523791
- Sponsor's protocol ID
- 4803
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can we Add Whey Protein Supplementation in Patients With Parkinson's Disease Without Interfering With Levodopa Response?
- ClinicalTrials.gov ID
- NCT05523791
- Acronym / sponsor ID
- 4803
- Conditions
- Parkinson Disease
- Keywords
- levodopa, whey protein supplementation, aerobic rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WPS | Experimental | Dietary Supplement: FortiralPatients continued their standard therapy, received a standard protein redistribution dietary regimen plus a whey protein-based oral formula twice a day |
| Mg | Active comparator | Dietary Supplement: Mg++Patients continued their standard therapy, received a standard protein redistribution dietary regimen plus 2.250g of magnesium pidolate twice a day |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- cognitive decline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FortiralTwice 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 supplement | WPS |
| 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 | Dietary supplement | Mg |
Primary outcome
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,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortiral and Mg++ in people with Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of maintained efficacy of dopaminergic therapy in WPS group (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.