Disability PhysicalNCT03124277
Nutritional Support for Rehabilitation In Parkinsonism
A study testing Fortifit® in people with Disability Physical, run by Emanuele Cereda at 1 site in Italy.
Trial summary
This randomized, trial will tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium would increase the efficacy of physical rehabilitation in old adults suffering from Parkinson's disease o parkinsonism Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Disability Physical
- What is being tested?
- Fortifit®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 26 Apr 2017to 17 Jan 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parkinson's disease o parkinsonism
- admission for physical rehabilitation
- Informed consent
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Refusal
Who cannot join
- Any malignant disease during the last five years
- Known kidney failure (previous glomerular filtration rate <30 ml/min);
- Known liver failure (Child B or C)
- Psychiatric disease
- Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
- Indications related to the study product:
Show all 9Show fewer
- More than 10 μg (400 IU) of daily Vitamin D intake from medical sources More than 500 mg of daily calcium intake from medical sources. Adherence to a high energy or high protein diet up or use of protein containing or amino acid containing nutritional supplements up to three months before starting the study.
- Known allergy to milk, milk products or other components of the proposed interventions
- Indication to or ongoing artificial nutrition support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Whey Protein-based Nutritional Supplement Enriched in Vitamin D, Leucine and Calcium for Patients With Parkinsonism Undergoing Rehabilitation Treatment: a Randomized Trial
This randomized, trial will tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium would increase the efficacy of physical rehabilitation in old adults suffering from Parkinson's disease o parkinsonism
- Conditions
- Disability Physical
- Being tested
- Fortifit®, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fortifit®Dietary supplement
Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
Control GroupOther
Best local diet
| Study group | Role | What they receive |
|---|---|---|
| Fortifit® | Experimental | Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. Receives: Dietary Supplement: Fortifit® |
| Control group | Other | Best local diet Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status - distance walked during the six minutes walking test
Change in the distance walked during the six minutes walking test
Measured: 30 days
Secondary outcomes (9)
Functional status - timed up and go test
Change in timed up and go test
Measured: 30 days
Functional status - Berg balance scale
Change in Berg balance scale score
Measured: 30 days
Functional status - handgrip strength
Change in handgrip strength
Measured: 30 days
Functional status - gait speed
Change in gait speed (4 minutes walking test)
Measured: 30 days
Self-perceived functional status
Change in Self-assessment Parkinson's Disease Disability Scale
Measured: 30 days
Body weight
Change in body weight
Measured: 30 days
Muscle mass
Change in muscle mass
Measured: 30 days
Adverse events
Occurrence of adverse events
Measured: 30 days
Treatment continuation
Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start26 Apr 2017
- Primary completion17 Jan 2018
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disability PhysicalStudies 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
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emanuele Cereda
- Sponsor type
- University, hospital or other
- Collaborators
- ASST Gaetano Pini-CTO, U.S. Riabilitazione Parkinson, Fondazione Gaetano e Piera Borghi di Brebbia, Ospedale Generale Di Zona Moriggia-Pelascini
- Responsible party
- Sponsor-investigator, Emanuele Cereda, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Michela Barichella, MD, Principal investigator, Centro Parkinson, ASST Gaetano Pini-CTO di Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124277
- Sponsor's protocol ID
- 184_2017
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2017
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barichella M, Cereda E, Pinelli G, Iorio L, Caroli D, Masiero I, Ferri V, Cassani E, Bolliri C, Caronni S, Maggio M, Ortelli P, Ferrazzoli D, Maras A, Riboldazzi G, Frazzitta G, Pezzoli G. Muscle-targeted nutritional support for rehabilitation in patients with parkinsonian syndrome. Neurology. 2019 Jul 30;93(5):e485-e496. doi: 10.1212/WNL.0000000000007858. Epub 2019 Jul 5.
PubMed 31278117
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Whey Protein-based Nutritional Supplement Enriched in Vitamin D, Leucine and Calcium for Patients With Parkinsonism Undergoing Rehabilitation Treatment: a Randomized Trial
- ClinicalTrials.gov ID
- NCT03124277
- Acronym / sponsor ID
- 184_2017
- Conditions
- Disability Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Emanuele CeredaUniversity, hospital or other
- Collaborators
- ASST Gaetano Pini-CTO, U.S. Riabilitazione Parkinson, Fondazione Gaetano e Piera Borghi di Brebbia, Ospedale Generale Di Zona Moriggia-Pelascini
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 21 Apr 2017 (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.
This randomized, trial will tested the hypothesis that nutritional supplementation with whey protein, essential amino acids - mainly leucine - vitamin D and calcium would increase the efficacy of physical rehabilitation in old adults suffering from Parkinson's disease o parkinsonism
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fortifit® | Experimental | Dietary Supplement: Fortifit®Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. |
| Control group | Other | Other: Control GroupBest local diet |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Parkinson's disease o parkinsonism
- admission for physical rehabilitation
- Informed consent
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Refusal
Key exclusion criteria (9 listed)
- Any malignant disease during the last five years
- Known kidney failure (previous glomerular filtration rate <30 ml/min);
- Known liver failure (Child B or C)
- Psychiatric disease
- Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
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 |
|---|---|---|
| Fortifit®Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers. | Dietary supplement | Fortifit® |
| Control GroupBest local diet | Other | Control group |
Primary outcome
Functional status - distance walked during the six minutes walking test
Time frame: 30 days
Change in the distance walked during the six minutes walking test
9 secondary outcomes
Functional status - timed up and go test
Time frame: 30 days
Functional status - Berg balance scale
Time frame: 30 days
Functional status - handgrip strength
Time frame: 30 days
Functional status - gait speed
Time frame: 30 days
Self-perceived functional status
Time frame: 30 days
Body weight
Time frame: 30 days
Muscle mass
Time frame: 30 days
Adverse events
Time frame: 30 days
Treatment continuation
Time frame: 30 days
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 1 May 2025.
- Derived from this study: PubMed 31278117Barichella M, Cereda E, Pinelli G, Iorio L, Caroli D, Masiero I, Ferri V, Cassani E, Bolliri C, Caronni S, Maggio M, Ortelli P, Ferrazzoli D, Maras A, Riboldazzi G, Frazzitta G, Pezzoli G. Muscle-targeted nutritional support for rehabilitation in patients with parkinsonian syndrome. Neurology. 2019 Jul 30;93(5):e485-e496. doi: 10.1212/WNL.0000000000007858. Epub 2019 Jul 5.
- 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.
Michela Barichella, MD principal investigator
Centro Parkinson, ASST Gaetano Pini-CTO di Milano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fortifit® in people with Disability Physical, run by Emanuele Cereda 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 5 inclusion and 9 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 1 May 2025. 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?
Functional status - distance walked during the six minutes walking test (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124277, which also lists 1 linked publication.
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 1 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.