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| ID | Type | Description | Link |
|---|---|---|---|
| RRC/2013/1281 | Other Identifier | Research Review Committee |
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| Name | Class |
|---|---|
| Agriculture and Agri-Food Canada | OTHER_GOV |
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This Clinical Trial is being conducted to study the LDL (bad) cholesterol lowering abilities of flax. The purpose of this study is to find the lowest dose of flax that can lower LDL-cholesterol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30g ground flaxseed per day | Experimental | consume 1 muffin containing 30g ground flaxseed every day for 4 weeks |
|
| 20g ground flaxseed per day | Experimental | consume 1 muffin containing 20g ground flaxseed every day for 4 weeks |
|
| 0g ground flaxseed per day | Placebo Comparator | consume 1 muffin containing 0g ground flaxseed every day for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| muffin | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| lipid profile | plasma total cholesterol, HDL, LDL and triglycerides | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| flax metabolites | plasma enterolignans and phospholipid fatty acid composition | 4 weeks |
| blood pressure | 4 weeks | |
| Measure | Description | Time Frame |
|---|---|---|
| gastrointestinal side effects | participants will be asked to document any abnormal gastrointestinal side effects (ie. abdominal bloating/swelling, flatulence, constipation, diarrhea, stomach pain, nausea, belching, vomiting, chocking/difficulty swallowing)in their study diary. | 4 weeks |
| liver function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather J Blewett, PhD | Agriculture and Agri-Food Canada | Principal Investigator |
| Thomas Wolever, PhD, MD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asper Clinical Research Institute | Winnipeg | Manitoba | R2H 2A6 | Canada | ||
| Glycemic Index Laboratories Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21160056 | Background | Roger VL, Go AS, Lloyd-Jones DM, Adams RJ, Berry JD, Brown TM, Carnethon MR, Dai S, de Simone G, Ford ES, Fox CS, Fullerton HJ, Gillespie C, Greenlund KJ, Hailpern SM, Heit JA, Ho PM, Howard VJ, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Makuc DM, Marcus GM, Marelli A, Matchar DB, McDermott MM, Meigs JB, Moy CS, Mozaffarian D, Mussolino ME, Nichol G, Paynter NP, Rosamond WD, Sorlie PD, Stafford RS, Turan TN, Turner MB, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2011 update: a report from the American Heart Association. Circulation. 2011 Feb 1;123(4):e18-e209. doi: 10.1161/CIR.0b013e3182009701. Epub 2010 Dec 15. | |
| 19812802 |
| Label | URL |
|---|---|
| Canadian health measures survey: Heart health and cholesterol levels of Canadians, 2007-2009 | View source |
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| high sensitivity c-reactive protein (hsCRP) |
| 4 weeks |
| glucose | 4 weeks |
plasma alanine aminotransferase (ALT) and aspartate aminotransferase (AST) |
| 4 weeks |
| kidney function | plasma creatinine and urea | 4 weeks |
| Muffin acceptability questionnaire | Questionnaire evaluating how much the participants liked or disliked the muffins in terms of color, aroma, flavor, texture, overall acceptability and frequency of eating of the muffin after the study is complete. The questionnaire will be administered at the end of each phase after the participant has been consuming the muffin every day for 4 weeks. | 4 weeks |
| Toronto |
| Ontario |
| M5C 2N8 |
| Canada |
| Background |
| Genest J, McPherson R, Frohlich J, Anderson T, Campbell N, Carpentier A, Couture P, Dufour R, Fodor G, Francis GA, Grover S, Gupta M, Hegele RA, Lau DC, Leiter L, Lewis GF, Lonn E, Mancini GB, Ng D, Pearson GJ, Sniderman A, Stone JA, Ur E. 2009 Canadian Cardiovascular Society/Canadian guidelines for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease in the adult - 2009 recommendations. Can J Cardiol. 2009 Oct;25(10):567-79. doi: 10.1016/s0828-282x(09)70715-9. |
| 21291759 | Background | Charland SL, Cziraky MJ, Quimbo R, Karas RH, Insull W Jr, Davidson M, Stanek EJ. Achieving optimal lipid values in patients with dyslipidemia is associated with reduced risk of cardiovascular events. J Clin Lipidol. 2008 Oct;2(5):343-53. doi: 10.1016/j.jacl.2008.06.009. Epub 2008 Jun 26. |
| 11001066 | Background | Lusis AJ. Atherosclerosis. Nature. 2000 Sep 14;407(6801):233-41. doi: 10.1038/35025203. |
| 12022246 | Background | O'Rourke MF, Staessen JA, Vlachopoulos C, Duprez D, Plante GE. Clinical applications of arterial stiffness; definitions and reference values. Am J Hypertens. 2002 May;15(5):426-44. doi: 10.1016/s0895-7061(01)02319-6. |
| 18716354 | Background | Xu Y, Wu Y, Li J, Ma W, Guo X, Luo Y, Hu D. The predictive value of brachial-ankle pulse wave velocity in coronary atherosclerosis and peripheral artery diseases in urban Chinese patients. Hypertens Res. 2008 Jun;31(6):1079-85. doi: 10.1291/hypres.31.1079. |
| 8973232 | Background | Leng GC, Fowkes FG, Lee AJ, Dunbar J, Housley E, Ruckley CV. Use of ankle brachial pressure index to predict cardiovascular events and death: a cohort study. BMJ. 1996 Dec 7;313(7070):1440-4. doi: 10.1136/bmj.313.7070.1440. |
| 12963567 | Background | Murabito JM, Evans JC, Larson MG, Nieto K, Levy D, Wilson PW; Framingham Study. The ankle-brachial index in the elderly and risk of stroke, coronary disease, and death: the Framingham Study. Arch Intern Med. 2003 Sep 8;163(16):1939-42. doi: 10.1001/archinte.163.16.1939. |
| 21390942 | Background | Singh KK, Mridula D, Rehal J, Barnwal P. Flaxseed: a potential source of food, feed and fiber. Crit Rev Food Sci Nutr. 2011 Mar;51(3):210-22. doi: 10.1080/10408390903537241. |
| 19935863 | Background | Bassett CM, Rodriguez-Leyva D, Pierce GN. Experimental and clinical research findings on the cardiovascular benefits of consuming flaxseed. Appl Physiol Nutr Metab. 2009 Oct;34(5):965-74. doi: 10.1139/H09-087. |
| 18689552 | Background | Austria JA, Richard MN, Chahine MN, Edel AL, Malcolmson LJ, Dupasquier CM, Pierce GN. Bioavailability of alpha-linolenic acid in subjects after ingestion of three different forms of flaxseed. J Am Coll Nutr. 2008 Apr;27(2):214-21. doi: 10.1080/07315724.2008.10719693. |
| 18053310 | Background | Zhang W, Wang X, Liu Y, Tian H, Flickinger B, Empie MW, Sun SZ. Dietary flaxseed lignan extract lowers plasma cholesterol and glucose concentrations in hypercholesterolaemic subjects. Br J Nutr. 2008 Jun;99(6):1301-9. doi: 10.1017/S0007114507871649. Epub 2007 Dec 6. |
| 21631511 | Background | Othman RA, Moghadasian MH, Jones PJ. Cholesterol-lowering effects of oat beta-glucan. Nutr Rev. 2011 Jun;69(6):299-309. doi: 10.1111/j.1753-4887.2011.00401.x. |
| 18460483 | Background | Bloedon LT, Balikai S, Chittams J, Cunnane SC, Berlin JA, Rader DJ, Szapary PO. Flaxseed and cardiovascular risk factors: results from a double blind, randomized, controlled clinical trial. J Am Coll Nutr. 2008 Feb;27(1):65-74. doi: 10.1080/07315724.2008.10719676. |
| 7825540 | Background | Cunnane SC, Hamadeh MJ, Liede AC, Thompson LU, Wolever TM, Jenkins DJ. Nutritional attributes of traditional flaxseed in healthy young adults. Am J Clin Nutr. 1995 Jan;61(1):62-8. doi: 10.1093/ajcn/61.1.62. |
| 15613422 | Background | Dodin S, Lemay A, Jacques H, Legare F, Forest JC, Masse B. The effects of flaxseed dietary supplement on lipid profile, bone mineral density, and symptoms in menopausal women: a randomized, double-blind, wheat germ placebo-controlled clinical trial. J Clin Endocrinol Metab. 2005 Mar;90(3):1390-7. doi: 10.1210/jc.2004-1148. Epub 2004 Dec 21. |
| 11932276 | Background | Lucas EA, Wild RD, Hammond LJ, Khalil DA, Juma S, Daggy BP, Stoecker BJ, Arjmandi BH. Flaxseed improves lipid profile without altering biomarkers of bone metabolism in postmenopausal women. J Clin Endocrinol Metab. 2002 Apr;87(4):1527-32. doi: 10.1210/jcem.87.4.8374. |
| 18328014 | Background | Patade A, Devareddy L, Lucas EA, Korlagunta K, Daggy BP, Arjmandi BH. Flaxseed reduces total and LDL cholesterol concentrations in Native American postmenopausal women. J Womens Health (Larchmt). 2008 Apr;17(3):355-66. doi: 10.1089/jwh.2007.0359. |
| 20007337 | Background | Simbalista RL, Sauerbronn AV, Aldrighi JM, Areas JA. Consumption of a flaxseed-rich food is not more effective than a placebo in alleviating the climacteric symptoms of postmenopausal women. J Nutr. 2010 Feb;140(2):293-7. doi: 10.3945/jn.109.113886. Epub 2009 Dec 9. |
| 12485966 | Background | National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002 Dec 17;106(25):3143-421. No abstract available. |