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The objective of this study is to evaluate the effect of the administration of 25 g of chia per day, for 90 days on the biochemical components of the metabolic syndrome in subjects with this condition
The metabolic syndrome (MS) is a cardiovascular risk factor and is present in about 20-25% of the world's adult population. Individuals with this condition have twice the risk of cardiovascular disease and die from it, compared with those who do not and 5 times more likely to develop type 2 diabetes mellitus (DM2). For this reason, it is appropriate to develop better tools for prevention and management of MS, with more emphasis on lifestyle´s changes. Chia has been studied in the past 10 years due to its high concentration of omega-3 alpha-linolenic acid (ALA) and 6 linoleic acid (LA) showing beneficial effects in some components of MS in rodents and individuals. The addition of chia to the conventional treatment of MS for the modification of metabolic disorders provides us a tool for easy incorporation into daily life, inexpensive and accessible in our environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Free diet plus Chia | Experimental | This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days without changing their diet |
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| Normocaloric diet plus chia | Experimental | This subjects will consume 1 cookie oatmeal with chia before breakfast and dinner for 90 days along with a normocaloric diet |
|
| Normocaloric diet plus oatmeal | Active Comparator | This subjects will consume 1 cookie oatmeal before breakfast and dinner for 90 days along with a normocaloric diet |
|
| Normocaloric diet | Active Comparator | This subjects will only go under a normocaloric diet for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chia | Dietary Supplement | The subject will eat 25 gr of chia in 2 oatmeal cookies at day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum glucose levels | Fasting, postprandial and post challenge oral test glucose and HbA1c | 94 days (plus or minus 4 days) |
| Variation in lipid profile | Triglycerides, HDL-cholesterol, LDL-cholesterol and total cholesterol | 94 days (plus or minus 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Modification in insulin resistance | Serum insulin, homeostasis model assessment index | 94 days (plus or minus 4 days) |
| Change in systolic blood pressure | 94 days (plus or minus 4 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana E Perez Verdin, MD | Contact | 011523336170060 | 31465 | verdinmd@hotmail.com |
| Blanca M Torres Mendoza, PhD | Contact | 011523336170060 | 31950 | bltorres1@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ana E Perez Verdin, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Mexicano Del Seguro Social Hospital de Especialidades, Centro Medico Nacional de Occidente Lic. Ignacio Garcia Tellez Unidad Medica de Alta Especialidad | Recruiting | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23251075 | Result | Mohd Ali N, Yeap SK, Ho WY, Beh BK, Tan SW, Tan SG. The promising future of chia, Salvia hispanica L. J Biomed Biotechnol. 2012;2012:171956. doi: 10.1155/2012/171956. Epub 2012 Nov 21. | |
| 17356263 | Result | Ayerza R Jr, Coates W. Effect of dietary alpha-linolenic fatty acid derived from chia when fed as ground seed, whole seed and oil on lipid content and fatty acid composition of rat plasma. Ann Nutr Metab. 2007;51(1):27-34. doi: 10.1159/000100818. Epub 2007 Mar 14. |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000715327 | Salvia hispanica seed extract |
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| Oatmeal | Dietary Supplement | The subject will eat 2 oatmeal cookies a day containing the exactly same quantity of oats in the oatmeal cookies with chia. |
|
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| Normocaloric diet | Behavioral | The healthy diet plan distribution will be 50% carbohydrate, 25 % protein, 35 % fat to less than 7 % saturated fat and less than 200 mg/d cholesterol and 20-30 g of fiber. |
|
| Change in diastolic blood pressure | 94 days (plus or minus 4 days) |
| Variation in body weight | 94 days (plus or minus 4 days) |
| Modification in waist circumference | 94 days (plus or minus 4 days) |
|
| 18492301 | Result | Chicco AG, D'Alessandro ME, Hein GJ, Oliva ME, Lombardo YB. Dietary chia seed (Salvia hispanica L.) rich in alpha-linolenic acid improves adiposity and normalises hypertriacylglycerolaemia and insulin resistance in dyslipaemic rats. Br J Nutr. 2009 Jan;101(1):41-50. doi: 10.1017/S000711450899053X. Epub 2008 May 20. |
| 22947172 | Result | Rossi AS, Oliva ME, Ferreira MR, Chicco A, Lombardo YB. Dietary chia seed induced changes in hepatic transcription factors and their target lipogenic and oxidative enzyme activities in dyslipidaemic insulin-resistant rats. Br J Nutr. 2013 May;109(9):1617-27. doi: 10.1017/S0007114512003558. Epub 2012 Sep 5. |
| 24120122 | Result | Oliva ME, Ferreira MR, Chicco A, Lombardo YB. Dietary Salba (Salvia hispanica L) seed rich in alpha-linolenic acid improves adipose tissue dysfunction and the altered skeletal muscle glucose and lipid metabolism in dyslipidemic insulin-resistant rats. Prostaglandins Leukot Essent Fatty Acids. 2013 Oct;89(5):279-89. doi: 10.1016/j.plefa.2013.09.010. Epub 2013 Sep 25. |
| 21429727 | Result | Poudyal H, Panchal SK, Waanders J, Ward L, Brown L. Lipid redistribution by alpha-linolenic acid-rich chia seed inhibits stearoyl-CoA desaturase-1 and induces cardiac and hepatic protection in diet-induced obese rats. J Nutr Biochem. 2012 Feb;23(2):153-62. doi: 10.1016/j.jnutbio.2010.11.011. Epub 2011 Mar 22. |
| 17686832 | Result | Vuksan V, Whitham D, Sievenpiper JL, Jenkins AL, Rogovik AL, Bazinet RP, Vidgen E, Hanna A. Supplementation of conventional therapy with the novel grain Salba (Salvia hispanica L.) improves major and emerging cardiovascular risk factors in type 2 diabetes: results of a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2804-10. doi: 10.2337/dc07-1144. Epub 2007 Aug 8. |
| 19628108 | Result | Nieman DC, Cayea EJ, Austin MD, Henson DA, McAnulty SR, Jin F. Chia seed does not promote weight loss or alter disease risk factors in overweight adults. Nutr Res. 2009 Jun;29(6):414-8. doi: 10.1016/j.nutres.2009.05.011. |
| 22538527 | Result | Jin F, Nieman DC, Sha W, Xie G, Qiu Y, Jia W. Supplementation of milled chia seeds increases plasma ALA and EPA in postmenopausal women. Plant Foods Hum Nutr. 2012 Jun;67(2):105-10. doi: 10.1007/s11130-012-0286-0. |
| 20087375 | Result | Vuksan V, Jenkins AL, Dias AG, Lee AS, Jovanovski E, Rogovik AL, Hanna A. Reduction in postprandial glucose excursion and prolongation of satiety: possible explanation of the long-term effects of whole grain Salba (Salvia Hispanica L.). Eur J Clin Nutr. 2010 Apr;64(4):436-8. doi: 10.1038/ejcn.2009.159. Epub 2010 Jan 20. |
| 23778782 | Result | Ho H, Lee AS, Jovanovski E, Jenkins AL, Desouza R, Vuksan V. Effect of whole and ground Salba seeds (Salvia Hispanica L.) on postprandial glycemia in healthy volunteers: a randomized controlled, dose-response trial. Eur J Clin Nutr. 2013 Jul;67(7):786-8. doi: 10.1038/ejcn.2013.103. Epub 2013 Jun 19. |
| 22090467 | Result | Guevara-Cruz M, Tovar AR, Aguilar-Salinas CA, Medina-Vera I, Gil-Zenteno L, Hernandez-Viveros I, Lopez-Romero P, Ordaz-Nava G, Canizales-Quinteros S, Guillen Pineda LE, Torres N. A dietary pattern including nopal, chia seed, soy protein, and oat reduces serum triglycerides and glucose intolerance in patients with metabolic syndrome. J Nutr. 2012 Jan;142(1):64-9. doi: 10.3945/jn.111.147447. Epub 2011 Nov 16. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D052439 | Lipid Metabolism Disorders |