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Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models

NCT02124330 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-03-09

No results posted yet for this study

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.

Conditions

  • Urea Cycle Disorders, Inborn
  • Other Metabolic Diseases

Interventions

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)

Sponsors & Collaborators

  • University of Trieste

    collaborator OTHER

  • Luca Ronfani

    lead OTHER

Principal Investigators

  • Tarcisio Not, MD · Institute for Maternal and Child Health IRCCS Burlo Garofolo

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02124330 on ClinicalTrials.gov