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Completed

NCT Number: NCT02124330

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.

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Key information

Conditions

Urea Cycle Disorders, Inborn Amino Acid Metabolism, Inborn Errors Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Other Metabolic Diseases

Age range

25 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • not defined

Treatment and study plan

montmorillonite 5 g

Dietary Supplement

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

montmorillonite 3 g

Dietary Supplement

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

Montmorillonite 1 g

Dietary Supplement

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

Primary outcomes

  1. Protein uptake evaluated with the blood MONT-protein ratio

    Time frame: before administration and 30, 60, 90, 120 ,180 minutes after

    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).

Secondary outcomes

  1. Protein absorption by MONT in vitro

    Time frame: at time of the trial

    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

Sponsors and collaborators

Lead sponsor

Luca Ronfani

Other

Collaborators

  • University of Trieste

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2014
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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