Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models

NCT02124330 | Completed

• 2 other identifiers: RC 06-13RC 06/13
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Montmorillonite, proteic diet, in vitro and in vivo models

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Protein absorption by MONT in vitro

  at time of the trial

Study Arms (4)

montmorillonite 5 g

EXPERIMENTAL

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

Dietary Supplement: montmorillonite 5 g

Montmorillonite 3 g

EXPERIMENTAL

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

Dietary Supplement: montmorillonite 3 g

Montmorillonite 1 g

EXPERIMENTAL

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

Dietary Supplement: Montmorillonite 1 g

Control

NO INTERVENTION

A control goup will intake 15 g of protein alone

Interventions

montmorillonite 5 g DIETARY_SUPPLEMENT

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

montmorillonite 5 g

montmorillonite 3 g DIETARY_SUPPLEMENT

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

Montmorillonite 3 g

Montmorillonite 1 g DIETARY_SUPPLEMENT

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

Montmorillonite 1 g

Eligibility Criteria

• Age: 25 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• not defined

Sponsors & Collaborators

• Luca Ronfani: lead
• University of Trieste: collaborator

Study Sites (1)

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

MeSH Terms

Conditions

Urea Cycle Disorders, Inborn

Interventions

Bentonite

Condition Hierarchy (Ancestors)

Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Aluminum Silicates; Aluminum Oxide; Aluminum Compounds; Inorganic Chemicals; Silicates; Minerals; Oxides; Oxygen Compounds; Silicic Acid; Silicon Dioxide; Silicon Compounds

Study Officials

• Tarcisio Not, MD

  Institute for Maternal and Child Health IRCCS Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: April 28, 2014
• Study Start: June 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

IT (1)