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| Name | Class |
|---|---|
| Centre de recherche du Centre hospitalier universitaire de Sherbrooke | OTHER |
| Solutex GC S.L. | INDUSTRY |
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Monoglyceride of DHA (DHA-MAG) is a lipid compound for which intestinal absorption would increase the ratio DHA / arachidonic acid (AA) and promote the synthesis of specific metabolites involved in the resolution of inflammation.
The PREMDIC project, initiated at the Centre Hospitalier Universitaire de Sherbrooke, is a randomized double-blind study for people with cystic fibrosis (CF) and aims to evaluate whether daily supplementation monoglyceride of DHA (a fatty acid omega-3 family) will reduce lung inflammation and improve pulmonary function.
The goal of the study is:
To investigate the efficacity of oral administration of MAG-DHA to increase DHA bioavailability and reduce lung inflammation of patients with cystic fibrosis
The specific objectives of the project are :
For this study, 20 cystic fibrosis patients are recruited. Patients are divided into 2 groups of 10 and received a daily dose equivalent to 3 g of placebo (sunflower oil) or MAG-DHA.
The project takes place over a period of 3 months and patients must travel to the research center for a total of five visits including recruitment.
For the 2 groups, DHA ratio / AA is measured in membranes of mononuclear cells. Forced expiratory volume in 1 second (FEV1) is determined and pHLE complexes are detected in plasma as a marker of inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAG-DHA | Active Comparator | MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days. |
|
| Placebo | Placebo Comparator | Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MAG-DHA | Dietary Supplement | MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lung and systemic inflammation measurement | Docosahexaenoic acid (DHA) and metabolites lipid analyses in plasma and red blood cells Human leukocyte elastase and alpha1 antitrypsin complexes detection in plasma Pulmonary function test (spirometry): Forced Expiratory Volume in 1 second (FEV1) and Forced Vital Capacity (FVC) Leukocytes differential cell counts and C reactive protein (CRP) determination level in blood | 0 and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| follow up of vital signs | weight (Kg) | 0 and 90 days |
| follow up of vital signs | Body Mass Index (BMI, Kg/cm2) | 0 and 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| André M Cantin, M.D. | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18036797 | Background | Al-Turkmani MR, Freedman SD, Laposata M. Fatty acid alterations and n-3 fatty acid supplementation in cystic fibrosis. Prostaglandins Leukot Essent Fatty Acids. 2007 Nov-Dec;77(5-6):309-18. doi: 10.1016/j.plefa.2007.10.009. Epub 2007 Nov 26. | |
| 18441018 | Background | Andersson C, Al-Turkmani MR, Savaille JE, Alturkmani R, Katrangi W, Cluette-Brown JE, Zaman MM, Laposata M, Freedman SD. Cell culture models demonstrate that CFTR dysfunction leads to defective fatty acid composition and metabolism. J Lipid Res. 2008 Aug;49(8):1692-700. doi: 10.1194/jlr.M700388-JLR200. Epub 2008 Apr 25. |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C575982 | docosahexaenoic acid monoacylglyceride |
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| Placebo | Dietary Supplement | Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days. |
|
| follow up of vital signs | Blood Pressure (mmHg) | 0 and 90 days |
| lipid profile | triglycerides (mmol/l) | 0 and 90 days |
| lipid profile | cholesterol (mmol/l) | 0 and 90 days |
| lipid profile | high density lipoprotein (mmol/l) | 0 and 90 days |
| lipid profile | low density lipoprotein (mmol/l) | 0 and 90 days |
| hepatic function | measurement of Alanine aminotransferase (ALT) in plasma (U/l) | 0 and 90 days |
| hepatic function | measurement of Aspartate aminotransferase (AST) in plasma (U/l) | 0 and 90 days |
| hepatic function | measurement of Gamma glutamyl transpeptidase in plasma (U/l) | 0 and 90 days |
| 7697269 | Background | Cantin A. Cystic fibrosis lung inflammation: early, sustained, and severe. Am J Respir Crit Care Med. 1995 Apr;151(4):939-41. doi: 10.1164/ajrccm.151.4.7697269. No abstract available. |
| 20638827 | Background | Dyerberg J, Madsen P, Moller JM, Aardestrup I, Schmidt EB. Bioavailability of marine n-3 fatty acid formulations. Prostaglandins Leukot Essent Fatty Acids. 2010 Sep;83(3):137-41. doi: 10.1016/j.plefa.2010.06.007. |
| Background | Fortin S, Compositions comprising polyunsaturated fatty acid monoglycerides or derivatives thereof and uses thereof, US819690, 2012, US8222295, 2012. |
| Background | Fortin S, Polyunsaturated fatty acid monoglycerides, derivatives, and uses thereof, CA2672513, 2008, CA2677670, 2010, US8119690, 2011. |
| 10570187 | Background | Freedman SD, Katz MH, Parker EM, Laposata M, Urman MY, Alvarez JG. A membrane lipid imbalance plays a role in the phenotypic expression of cystic fibrosis in cftr(-/-) mice. Proc Natl Acad Sci U S A. 1999 Nov 23;96(24):13995-4000. doi: 10.1073/pnas.96.24.13995. |
| 19828687 | Background | Mimoun M, Coste TC, Lebacq J, Lebecque P, Wallemacq P, Leal T, Armand M. Increased tissue arachidonic acid and reduced linoleic acid in a mouse model of cystic fibrosis are reversed by supplemental glycerophospholipids enriched in docosahexaenoic acid. J Nutr. 2009 Dec;139(12):2358-64. doi: 10.3945/jn.109.110999. Epub 2009 Oct 14. |
| 21057106 | Background | Morin C, Fortin S, Cantin AM, Rousseau E. Docosahexaenoic acid derivative prevents inflammation and hyperreactivity in lung: implication of PKC-Potentiated inhibitory protein for heterotrimeric myosin light chain phosphatase of 17 kD in asthma. Am J Respir Cell Mol Biol. 2011 Aug;45(2):366-75. doi: 10.1165/rcmb.2010-0156OC. Epub 2010 Nov 5. |
| 23092161 | Background | Morin C, Fortin S, Cantin AM, Sirois M, Sirois C, Rizcallah E, Rousseau E. Anti-cancer effects of a new docosahexaenoic acid monoacylglyceride in lung adenocarcinoma. Recent Pat Anticancer Drug Discov. 2013 Sep;8(3):319-34. doi: 10.2174/1574891x113089990032. |
| 16325968 | Background | Panchaud A, Sauty A, Kernen Y, Decosterd LA, Buclin T, Boulat O, Hug C, Pilet M, Roulet M. Biological effects of a dietary omega-3 polyunsaturated fatty acids supplementation in cystic fibrosis patients: a randomized, crossover placebo-controlled trial. Clin Nutr. 2006 Jun;25(3):418-27. doi: 10.1016/j.clnu.2005.10.011. Epub 2005 Dec 2. |
| 21297610 | Background | Pier G, Prince A, Cantin A. Cystic fibrosis: an-ion transport issue? Nat Med. 2011 Feb;17(2):166-7. doi: 10.1038/nm0211-166. |
| 19247502 | Background | Vij N, Mazur S, Zeitlin PL. CFTR is a negative regulator of NFkappaB mediated innate immune response. PLoS One. 2009;4(2):e4664. doi: 10.1371/journal.pone.0004664. Epub 2009 Feb 27. |
| 22863555 | Result | Cantin AM, Bilodeau G, Larivee P, Richter MV. Plasma biomarkers and cystic fibrosis lung disease. Clin Invest Med. 2012 Jul 4;35(4):E173-81. doi: 10.25011/cim.v35i4.17145. |
| 25781052 | Result | Morin C, Cantin AM, Rousseau E, Sirois M, Sirois C, Rizcallah E, Fortin S. Proresolving Action of Docosahexaenoic Acid Monoglyceride in Lung Inflammatory Models Related to Cystic Fibrosis. Am J Respir Cell Mol Biol. 2015 Oct;53(4):574-83. doi: 10.1165/rcmb.2014-0223OC. |
| 29861448 | Derived | Morin C, Cantin AM, Vezina FA, Fortin S. The Efficacy of MAG-DHA for Correcting AA/DHA Imbalance of Cystic Fibrosis Patients. Mar Drugs. 2018 May 26;16(6):184. doi: 10.3390/md16060184. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |