Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
76 participants
INTERVENTIONAL
2014-01-31
2025-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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30g ground flaxseed per day
consume 1 muffin containing 30g ground flaxseed every day for 4 weeks
muffin
20g ground flaxseed per day
consume 1 muffin containing 20g ground flaxseed every day for 4 weeks
muffin
0g ground flaxseed per day
consume 1 muffin containing 0g ground flaxseed every day for 4 weeks
muffin
Interventions
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muffin
Eligibility Criteria
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Inclusion Criteria
* Body mass index 18.5-40.0 kg/m2
* Fasting plasma LDL cholesterol 2.6-5.0 mmol/L
* Regular dietary habits (ie. breakfast, lunch and dinner meals consumed daily)
* Willing to comply with protocol requirements
* Willing to provide informed consent
Exclusion Criteria
* Fasting plasma triglycerides ≥ 4.0 mmol/L
* Medical history of diabetes mellitus, fasting plasma glucose ≥ 7.0 mmol/L or use of insulin or oral medication to control blood sugar
* Medical history of gastrointestinal disease, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks
* Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis)
* Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥ 1.5 times the upper limit of normal (ULN))
* Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN)
* Active treatment for any type of cancer within 1 year prior to study start
* Major surgery within the last 3 months
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
* Unstable body weight (defined as \> 5% change in 3 months) or actively participating in a weight loss program
* Tobacco and/or nicotine replacement use, current or within the last 3 months
* Taking medication (prescription or non-prescription) or dietary supplements (pre/probiotics, vitamins, minerals, fats, herbals) known to affect blood lipids, with the exception of stable doses of thyroxine and oral contraceptive agents
* Any food allergy, aversion or unwillingness to eat wheat or flax
* Daily consumption of flax containing products in the past month
* Regular intake of \> 2 alcoholic drinks per day. Standard drink (13.6 g alcohol)= Beer (5% alcohol) 360 mL (12 fl.oz); Spirits (40% alcohol) 45 mL (1.5 fl.oz); wine (12% alcohol) 150 mL (5 fl.oz)
* Participation in another clinical trial, current or in the past 4 weeks
30 Years
65 Years
ALL
Yes
Sponsors
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Agriculture and Agri-Food Canada
OTHER_GOV
St. Boniface Hospital
OTHER
Responsible Party
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Dr. Heather Blewett
Principal Investigator
Principal Investigators
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Heather J Blewett, PhD
Role: PRINCIPAL_INVESTIGATOR
Agriculture and Agri-Food Canada
Thomas Wolever, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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Asper Clinical Research Institute
Winnipeg, Manitoba, Canada
Glycemic Index Laboratories Inc.
Toronto, Ontario, Canada
Countries
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References
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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.
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.
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.
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.
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.
Lusis AJ. Atherosclerosis. Nature. 2000 Sep 14;407(6801):233-41. doi: 10.1038/35025203.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Canadian health measures survey: Heart health and cholesterol levels of Canadians, 2007-2009
Other Identifiers
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RRC/2013/1281
Identifier Type: OTHER
Identifier Source: secondary_id
B2013:012
Identifier Type: -
Identifier Source: org_study_id
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