Other Metabolic Diseases, Urea Cycle Disorders, Inborn
Conditions
Keywords
Montmorillonite, proteic diet, in vitro and in vivo models
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTmontmorillonite 5 g
5g montmorillonite + 15 g protein (ratio 1:3)
DIETARY_SUPPLEMENTmontmorillonite 3 g
3g MONT+ 15 g protein (ratio 1:5)
DIETARY_SUPPLEMENTMontmorillonite 1 g
1g MONT+ 15 g protein (ratio 1:15)
Sponsors
University of Trieste
Luca Ronfani
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy volunteers (12M, 13 F, 25-30 years). Fasting from morning
Exclusion criteria
* not defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Protein uptake evaluated with the blood MONT-protein ratio | 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
| Measure | Time frame | Description |
|---|---|---|
| Protein absorption by MONT in vitro | 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 |
Countries
Italy
Outcome results
None listed