NCT02124330

Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Luca Ronfani · Academic / Other
• Sex: All
• Age: 25 Years – 30 Years
• Healthy volunteers: Accepted

Summary

Montmorillonite (MONT) is a phyllosilicate layered mineral with unique physicochemical properties, such as swelling and cation exchange capability. The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to reduce protein intestinal uptake. Furthermore, the study analyzed in vitro the MONT ability of immobilizing proteins.

Detailed description

Montmorillonite (MONT) is a phyllosilicate layered mineral; chemically it is hydrated sodium calcium aluminium magnesium silicate hydroxide. Potassium, iron, and other cations are common substitutes and the exact ratio of cations varies with source. Due to its unique physicochemical properties, such as swelling and cation exchange capability, as well its mechanical and thermal stability, MONT can be efficiently used as matrix for immobilization of proteins with high molecular weight (e.g. Albumin) and proteins with low molecular weight (e.g.Aflatoxines). Therefore, MONT is used for therapeutic purposes, in pharmaceutical formulations and in food preparations. In vitro assays made in our laboratory, showed that MONT absorbs, in stable manner, alimentary proteins: beta-lactoglobulins, alfa lactoalbumines and the ratio MONT-protein (w/w) 1:3, 1:5, 1:15, results in the protein capture of 50, 27, 0 % of proteins respectively. The aim of this project is to study, in healthy volunteers, the in vivo ability of MONT to reduce protein intestinal uptake evaluated with the blood MONT- protein ratio. Furthermore, the study analyzed in vitro the MONT ability of immobilizing proteins at different ratio (w/w) 1:3, 1:5, 1:15.

Conditions

• Urea Cycle Disorders, Inborn
• Other Metabolic Diseases

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	montmorillonite 5 g	5g montmorillonite + 15 g protein (ratio 1:3)
DIETARY_SUPPLEMENT	montmorillonite 3 g	3g MONT+ 15 g protein (ratio 1:5)
DIETARY_SUPPLEMENT	Montmorillonite 1 g	1g MONT+ 15 g protein (ratio 1:15)

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2014-04-28
• Last updated: 2017-03-09

Locations

1 site across 1 country: Italy