Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models

Luca Ronfani

Status: Completed

Conditions: Urea Cycle Disorders, Inborn; Other Metabolic Diseases

Treatments: Dietary Supplement: montmorillonite 3 g; Dietary Supplement: Montmorillonite 1 g; Dietary Supplement: montmorillonite 5 g

Study type: Interventional

Funder types: Other

Identifiers

NCT02124330

RC 06/13 (Other Identifier)

RC 06-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 25 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy volunteers (12M, 13 F, 25-30 years). Fasting from morning

Exclusion criteria

• not defined

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 4 patient groups

montmorillonite 5 g

Experimental group

Description:

5g Montmorillonite + 15 g protein (ratio 1:3)

Treatment:

Dietary Supplement: montmorillonite 5 g

Montmorillonite 3 g

Experimental group

Description:

3g Montmorillonite + 15 g protein (ratio 1:5)

Treatment:

Dietary Supplement: montmorillonite 3 g

Montmorillonite 1 g

Experimental group

Description:

1g Montmorillonite + 15 g protein (ratio 1:15)

Treatment:

Dietary Supplement: Montmorillonite 1 g

Control

No Intervention group

Description:

A control goup will intake 15 g of protein alone