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| ID | Type | Description | Link |
|---|---|---|---|
| RC 06/13 | Other Identifier | IRCCS Burlo Garofolo |
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| Name | Class |
|---|---|
| University of Trieste | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| montmorillonite 5 g | Experimental | 5g Montmorillonite + 15 g protein (ratio 1:3) |
|
| Montmorillonite 3 g | Experimental | 3g Montmorillonite + 15 g protein (ratio 1:5) |
|
| Montmorillonite 1 g | Experimental | 1g Montmorillonite + 15 g protein (ratio 1:15) |
|
| Control | No Intervention | A control goup will intake 15 g of protein alone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montmorillonite 5 g | Dietary Supplement | 5g montmorillonite + 15 g protein (ratio 1:3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tarcisio Not, MD | Institute for Maternal and Child Health IRCCS Burlo Garofolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for Maternal and Child Health IRCCS Burlo Garofolo | Trieste | Friuli Venezia Giulia | 34137 | Italy |
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| ID | Term |
|---|---|
| D056806 | Urea Cycle Disorders, Inborn |
| ID | Term |
|---|---|
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D001546 | Bentonite |
| ID | Term |
|---|---|
| D000538 | Aluminum Silicates |
| D000537 | Aluminum Oxide |
| D017607 | Aluminum Compounds |
| D007287 | Inorganic Chemicals |
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| montmorillonite 3 g | Dietary Supplement | 3g MONT+ 15 g protein (ratio 1:5) |
|
| Montmorillonite 1 g | Dietary Supplement | 1g MONT+ 15 g protein (ratio 1:15) |
|
| at time of the trial |
| D009422 | Nervous System Diseases |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D017640 |
| Silicates |
| D008903 | Minerals |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D012824 | Silicic Acid |
| D012822 | Silicon Dioxide |
| D017655 | Silicon Compounds |