Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models

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.

Study Overview

• Status: Completed
• Conditions: Urea Cycle Disorders, Inborn; Other Metabolic Diseases
• Intervention / Treatment: Dietary supplement: montmorillonite 5 g; Dietary supplement: montmorillonite 3 g; Dietary supplement: Montmorillonite 1 g

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Friuli Venezia Giulia
    • Trieste, Friuli Venezia Giulia, Italy, 34137
      • Institute for Maternal and Child Health IRCCS Burlo Garofolo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• not defined

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: montmorillonite 5 g; 5g Montmorillonite + 15 g protein (ratio 1:3)	Dietary supplement: montmorillonite 5 g; 5g montmorillonite + 15 g protein (ratio 1:3)
Experimental: Montmorillonite 3 g; 3g Montmorillonite + 15 g protein (ratio 1:5)	Dietary supplement: montmorillonite 3 g; 3g MONT+ 15 g protein (ratio 1:5)
Experimental: Montmorillonite 1 g; 1g Montmorillonite + 15 g protein (ratio 1:15)	Dietary supplement: Montmorillonite 1 g; 1g MONT+ 15 g protein (ratio 1:15)
No Intervention: Control; A control goup will intake 15 g of protein alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein uptake evaluated with the blood MONT-protein ratio	A solution of MONT and whey protein dissolved in 200 ml of water at the three different ratios will be administered. The control group will intake 15g of protein alone. Blood samples will be centrifuged and analyzed by mass spectrometry (egilent HP5973 mass spectrometry).	before administration and 30, 60, 90, 120 ,180 minutes after

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protein absorption by MONT in vitro	MONT and protein (whey protein) at three different ratio w/w (1:3, 1:5, 1:15) will be dissolved in acetate buffer 0.1M pH5 as well as a sample without MONT. Samples will incubate at RT for 1, 10, 30, 60 minutes and then centrifugate at 13000g. The surnatant will be analyzed by LOWRY method. Protein concentration will be expressed in mg/ml. The MONT ability of immobilization will be calculated respect to the protein control sample	at time of the trial

Collaborators and Investigators

• Sponsor: Luca Ronfani
• Collaborators: University of Trieste
• Investigators: Principal Investigator: Tarcisio Not, MD, Institute for Maternal and Child Health IRCCS Burlo Garofolo

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (Estimate): April 28, 2014

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Montmorillonite, proteic diet, in vitro and in vivo models
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Brain Diseases, Metabolic; Brain Diseases, Metabolic, Inborn; Amino Acid Metabolism, Inborn Errors; Metabolic Diseases; Urea Cycle Disorders, Inborn; Physiological Effects of Drugs; Protective Agents; Antidotes; Bentonite
• Other Study ID Numbers: RC 06-13; RC 06/13 (Other Identifier: IRCCS Burlo Garofolo)