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临床试验/NCT02124330
NCT02124330已完成不适用

Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models

Luca Ronfani2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Protein uptake evaluated with the blood MONT-protein ratio

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
25 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • not defined

结局指标

主要结局

Protein uptake evaluated with the blood MONT-protein ratio

时间窗: 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).

次要结局

  • Protein absorption by MONT in vitro(at time of the trial)

研究者

发起方
Luca Ronfani
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Luca Ronfani

Dr

IRCCS Burlo Garofolo

研究点 (2)

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