Trial | NCT02124330  Report issue

Official Title

Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    montmorillonite ...

  • Study Participants

    35
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.
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.
Study Started
Jun 30
2013
Primary Completion
Apr 30
2015
Study Completion
Apr 30
2015
Last Update
Mar 09
2017

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)

montmorillonite 5 g Experimental

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

Montmorillonite 3 g Experimental

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

Montmorillonite 1 g Experimental

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

Control No Intervention

A control goup will intake 15 g of protein alone

Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

not defined
No Results Posted