Ignite Creation Date:
2024-05-06 @ 7:08 AM
Last Modification Date:
2024-10-26 @ 11:45 AM
Study NCT ID:
NCT02472119
Status:
UNKNOWN
Last Update Posted:
2015-06-15
First Post:
2015-06-03
Brief Title:
Wheat Flour Treatment With Microbial Transglutaminase and Lysine Ethyl Ester New Frontiers in Celiac Disease Treatment
Sponsor:
University of Roma La Sapienza
Organization:
University of Roma La Sapienza
Study Overview
Official Title:
Wheat Flour Subjected to Microbial Transglutaminase Enzymatic Treatment in the Presence of Lysine Ethyl Ester for Alimentary Use in the Treatment of Celiac Disease
Status:
UNKNOWN
Status Verified Date:
2015-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WHETMIT
Brief Summary:
Celiac disease is one of the most common forms of food intolerance prevalence 1200 The disease occurs in genetically predisposed individuals after ingestion of foods containing gluten Celiac patients can suffer from severe malabsorption syndrome mainly characterized by diarrhea and weight loss The only therapeutic approach currently recognized is a life-long gluten-free diet
Specific regions of gluten molecule become recognizable by lymphocytes and activate them due to changes made by tissue transglutaminase These changes consist in the conversion of specific residues of glutamine into glutamic acid The consequence is an increased binding affinity between gluten and histocompatibility molecule HLA-DQ2 localized on the surface of the antigen presenting cells APC the exposure of the fragments of modified gluten on the surface of APC is a phenomenon that eventually activates T lymphocytes
Recent studies on modified gluten confirmed the hypothesis that it is possible to block the presentation of gluten to lymphocytes by means of lysine ethyl ester binding exclusively to those gluten regions responsible for lymphocyte activation
The enzymatic treatment is performed directly on flour instead of extracted gluten maintaining the same anti-inflammatory effectiveness
The procedure uses a food-grade enzyme the microbial transglutaminase mTGasi isolated from Streptoverticillium mobarensis able to catalyze the formation of intermolecular cross-links that modify the functional properties of the products
Objective of the study is to validate the ability of the enzyme treatment of wheat flour with mTGasi and lysine ethyl ester to block the toxic effect of gluten in celiac patients
Specific regions of gluten molecule become recognizable by lymphocytes and activate them due to changes made by tissue transglutaminase These changes consist in the conversion of specific residues of glutamine into glutamic acid The consequence is an increased binding affinity between gluten and histocompatibility molecule HLA-DQ2 localized on the surface of the antigen presenting cells APC the exposure of the fragments of modified gluten on the surface of APC is a phenomenon that eventually activates T lymphocytes
Recent studies on modified gluten confirmed the hypothesis that it is possible to block the presentation of gluten to lymphocytes by means of lysine ethyl ester binding exclusively to those gluten regions responsible for lymphocyte activation
The enzymatic treatment is performed directly on flour instead of extracted gluten maintaining the same anti-inflammatory effectiveness
The procedure uses a food-grade enzyme the microbial transglutaminase mTGasi isolated from Streptoverticillium mobarensis able to catalyze the formation of intermolecular cross-links that modify the functional properties of the products
Objective of the study is to validate the ability of the enzyme treatment of wheat flour with mTGasi and lysine ethyl ester to block the toxic effect of gluten in celiac patients
Detailed Description:
Celiac disease is one of the most common forms of food intolerance prevalence 1200 The disease occurs in genetically predisposed individuals after ingestion of foods containing wheat gluten and similar proteins found in other common cereals such as barley and rye Celiac patients can suffer from severe malabsorption syndrome mainly characterized by diarrhea weight loss and growth retardation The only therapeutic approach currently recognized is a life-long gluten-free diet
Specific regions of gluten molecule become recognizable by lymphocytes and activate them due to changes made by tissue transglutaminase These changes consist in the conversion of specific residues of glutamine Q into glutamic acid E The consequence is an increased binding affinity between gluten and histocompatibility molecule HLA-DQ2 localized on the surface of the antigen presenting cells APC the exposure of the fragments of modified gluten on the surface of APC is a phenomenon that eventually activates T lymphocytes
Recent studies on modified gluten confirmed the hypothesis that it is possible to block the presentation of gluten to lymphocytes by means of lysine ethyl ester binding exclusively to those gluten regions responsible for lymphocyte activation
Specifically it is possible to perform the enzymatic treatment directly on flour instead of extracted gluten maintaining the same anti-inflammatory effectiveness The final procedure consists in dissolving the flour in water in the presence of appropriate concentrations of enzyme and lysine ethyl ester maintaining the suspension in constant motion for two hours at room temperature
The procedure uses a food-grade enzyme the microbial transglutaminase mTGasi isolated from Streptoverticillium mobarensis already used for the preparation of food The mTgasi is able to catalyze the formation of intermolecular cross-links modifying the functional properties of the products through the aggregation and polymerization of proteins The peculiar method identified by our laboratory reduces the possibility of cross-links between proteins consequently minimal changes involve the gluten structure and consequently the visco-elastic properties of the dough
Objective of the study is to validate the ability of the enzyme treatment of wheat flour with mTGasi and lysine ethyl ester to block the toxic effect of gluten in celiac patients
Specific regions of gluten molecule become recognizable by lymphocytes and activate them due to changes made by tissue transglutaminase These changes consist in the conversion of specific residues of glutamine Q into glutamic acid E The consequence is an increased binding affinity between gluten and histocompatibility molecule HLA-DQ2 localized on the surface of the antigen presenting cells APC the exposure of the fragments of modified gluten on the surface of APC is a phenomenon that eventually activates T lymphocytes
Recent studies on modified gluten confirmed the hypothesis that it is possible to block the presentation of gluten to lymphocytes by means of lysine ethyl ester binding exclusively to those gluten regions responsible for lymphocyte activation
Specifically it is possible to perform the enzymatic treatment directly on flour instead of extracted gluten maintaining the same anti-inflammatory effectiveness The final procedure consists in dissolving the flour in water in the presence of appropriate concentrations of enzyme and lysine ethyl ester maintaining the suspension in constant motion for two hours at room temperature
The procedure uses a food-grade enzyme the microbial transglutaminase mTGasi isolated from Streptoverticillium mobarensis already used for the preparation of food The mTgasi is able to catalyze the formation of intermolecular cross-links modifying the functional properties of the products through the aggregation and polymerization of proteins The peculiar method identified by our laboratory reduces the possibility of cross-links between proteins consequently minimal changes involve the gluten structure and consequently the visco-elastic properties of the dough
Objective of the study is to validate the ability of the enzyme treatment of wheat flour with mTGasi and lysine ethyl ester to block the toxic effect of gluten in celiac patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None