NCT05937802

Osmotin Plant Protein for Progressive Multiple Sclerosis

Exploratory Trial of Forza™️, a Novel Nutraceutical From Actinidia Deliciosa Plants Bioengineered to Bio-encapsulate the Osmotin Plant Protein as Adjuvant for the Treatment of Progressive Multiple Sclerosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ospedale Policlinico San Martino · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Progressive Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-02
• Primary completion: 2024-01-02
• Completion: 2025-01-02
• First posted: 2023-07-10
• Last updated: 2023-07-10

Locations

2 sites across 1 country: Italy