Osmotin Plant Protein for Progressive Multiple Sclerosis
NCT05937802 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2023-07-10
Summary
The aim of this study is to explore the anti-inflammatory and neuroprotective effects of a novel nutraceutical product (commercial name Forza™️), consisting of the plant osmotin protein, in patients with progressive multiple sclerosis (PMS). The potential effect on brain metabolism and microstructure will be evaluated by magnetic resonance imaging (MRI) performed six months before starting treatment, at baseline, and after one and six months of treatment. At the same timepoints, electrophysiology, neurofilaments (NfL) quantification, optical coherence tomography (OCT) and clinical assessments will be performed.
Conditions
Interventions
- DIETARY_SUPPLEMENT
-
Osmotin
Oral administration for 6 months of 7 capsules per day (4 in the morning and 3 in the evening) for a daily dosage of 5 grams.
Sponsors & Collaborators
-
Italian Multiple Sclerosis Foundation
collaborator OTHER -
S. Andrea Hospital
collaborator OTHER -
Ospedale Policlinico San Martino
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-02
- Primary Completion
- 2024-01-02
- Completion
- 2025-01-02
Countries
- Italy
Study Locations
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