Nutritional Support for Rehabilitation In Parkinsonism
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03124277 |
Recruitment Status :
Completed
First Posted : April 21, 2017
Last Update Posted : February 14, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Disability Physical | Dietary Supplement: Fortifit® Other: Control Group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 26, 2017 |
Actual Primary Completion Date : | January 17, 2018 |
Actual Study Completion Date : | January 17, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: 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®
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
Best local diet
|
Other: Control Group
Best local diet |
- 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
- Functional status - timed up and go test [ Time Frame: 30 days ]Change in timed up and go test
- Functional status - Berg balance scale [ Time Frame: 30 days ]Change in Berg balance scale score
- Functional status - handgrip strength [ Time Frame: 30 days ]Change in handgrip strength
- Functional status - gait speed [ Time Frame: 30 days ]Change in gait speed (4 minutes walking test)
- Self-perceived functional status [ Time Frame: 30 days ]Change in Self-assessment Parkinson's Disease Disability Scale
- Body weight [ Time Frame: 30 days ]Change in body weight
- Muscle mass [ Time Frame: 30 days ]Change in muscle mass
- Adverse events [ Time Frame: 30 days ]Occurrence of adverse events
- Treatment continuation [ Time Frame: 30 days ]Likelihood that patients would continue taking the trial treatment as assessed by a self-rating scale

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Parkinson's disease o parkinsonism
- admission for physical rehabilitation
- Informed consent
Exclusion Criteria:
- 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:
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
- Inclusion in other nutrition intervention trials
- Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
- Refusal

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124277
Italy | |
Centro Parkinson, ASST Gaetano Pini-CTO | |
Milano, Italy |
Principal Investigator: | Michela Barichella, MD | Centro Parkinson, ASST Gaetano Pini-CTO di Milano |
Responsible Party: | Emanuele Cereda, Co-Project Investigator, IRCCS Policlinico S. Matteo |
ClinicalTrials.gov Identifier: | NCT03124277 |
Other Study ID Numbers: |
184_2017 |
First Posted: | April 21, 2017 Key Record Dates |
Last Update Posted: | February 14, 2018 |
Last Verified: | February 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders |