Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models

Urea Cycle Disorders, Inborn Clinical Trial

Official title:

Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02124330
• Other study ID #: RC 06-13
• Secondary ID: RC 06/13
• Status: Completed
• Phase: N/A
• First received: October 21, 2013
• Last updated: March 8, 2017
• Start date: June 2013
• Est. completion date: April 2015

Study information

• Verified date: March 2017
• Source: IRCCS Burlo Garofolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 30 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• not defined

Related Conditions & MeSH terms

• Metabolic Diseases
• Other Metabolic Diseases
• Urea Cycle Disorders, Inborn

Intervention

Dietary Supplement:
• montmorillonite 5 g
5g montmorillonite + 15 g protein (ratio 1:3)
• montmorillonite 3 g
3g MONT+ 15 g protein (ratio 1:5)
• Montmorillonite 1 g
1g MONT+ 15 g protein (ratio 1:15)

Locations

Country	Name	City	State
Italy	Institute for Maternal and Child Health IRCCS Burlo Garofolo	Trieste	Friuli Venezia Giulia

Sponsors (2)

Lead Sponsor	Collaborator
Luca Ronfani	University of Trieste

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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