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Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to genetic and / or environmental factors such as inadequate dietary pattern. The occurrence of adverse events with statins, added to recent questions about their benefits on hard outcomes, opens a gap for the importance of seeking other forms of treatment of dyslipidemia, particularly in patients for secondary prevention. The consumption of oat bran, beta-glucan source of dietary fibers with supposed action in reducing the absorption of exogenous cholesterol and the endogenous synthesis of it, and source of avenanthramides, phytochemical compounds with alleged antioxidant in lipid membranes, can be effective strategy for secondary prevention of atherosclerotic disease.
Objectives: To evaluate the effect of nutritional counseling associated with the consumption of oat bran (40g per day) in lowering cholesterol, glucose profile and anthropometric parameters of subjects in secondary prevention, evaluate the quality of the diet and the intake of processed foods and ingredients added.
Methods: A randomized block, double-blind, placebo-controlled trial lasting 90 days. Inclusion criteria: individuals aged greater than 20 years, both genders, with LDL-c equal or higher than 130mg/dL fasting lipemia. Eligible individuals were considered using oral lipid-lowering, since the dose reported in the early nutritional intervention was maintained during the study. Exclusion criteria: patients requiring reduction in daily fluid intake, supplement use in dietary fiber and gestation / lactation. Data collected: gender; age; education; drugs; body mass (BM), height, body mass index (BMI), waist circumference (WC), neck circumference (NC); blood pressure; dietary surveys, total cholesterol (TC), LDL-C, HDL-cholesterol (HDL-c), triglycerides (TG), fasting glucose (GLU), fasting insulin (INS), HOMA-IR and QUICK. The diet quality was evaluated at baseline and end of study through the Diet Quality Index Revised (IQD-R). The sample size calculation was performed from a pilot study. It came to the need for 63 subjects for each group, oat bran group (GFAV) and placebo group (GPL). The level of statistical significance was 5% (p <0.05).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oat bran group | Active Comparator | oat bran (40g per day) |
|
| Placebo group | Placebo Comparator | refined rice flour (40g per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oat bran - 40g | Dietary Supplement | oat bran - 40g per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in LDL-cholesterol in three months | mesures assessed in baseline, after 30, 60 and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in glucose profile in three months | mesures assessed in baseline, after 30, 60 and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body mass | mesures in kg, assessed in baseline, after 30, 60 and 90 days | |
| Change from baseline in waist circumference | mesures in cm, assessed in baseline, after 30, 60 and 90 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simone R. Souza | Universidade Federal do Rio de Janeiro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Estadual de Cardiologia Aloysio de Castro - IECAC | Rio de Janeiro | Rio de Janeiro | 22261-010 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24814382 | Background | Adamsson V, Reumark A, Marklund M, Larsson A, Riserus U. Role of a prudent breakfast in improving cardiometabolic risk factors in subjects with hypercholesterolemia: a randomized controlled trial. Clin Nutr. 2015 Feb;34(1):20-6. doi: 10.1016/j.clnu.2014.04.009. Epub 2014 Apr 21. | |
| 22764134 | Background | Andersson KE, Hellstrand P. Dietary oats and modulation of atherogenic pathways. Mol Nutr Food Res. 2012 Jul;56(7):1003-13. doi: 10.1002/mnfr.201100706. Epub 2012 Jun 12. |
| Label | URL |
|---|---|
| WORLD HEALTH ORGANIZATION. Cardiovascular disease prevention and control. Translating evidence into action, 2005 | View source |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| refined rice flour- 40g |
| Dietary Supplement |
refined rice flour - 40g per day |
|
| Change from baseline in neck circumference | mesures in cm, assessed in baseline, after 30, 60 and 90 days |
| 24902970 | Background | Bentzon JF, Otsuka F, Virmani R, Falk E. Mechanisms of plaque formation and rupture. Circ Res. 2014 Jun 6;114(12):1852-66. doi: 10.1161/CIRCRESAHA.114.302721. |
| 21295870 | Background | Briel M, Vale N, Schwartz GG, de Lemos JA, Colivicchi F, den Hartog FR, Ostadal P, Macin SM, Liem A, Mills E, Bhatnagar N, Bucher HC, Nordmann AJ. Updated evidence on early statin therapy for acute coronary syndromes: meta-analysis of 18 randomized trials involving over 14,000 patients. Int J Cardiol. 2012 Jun 28;158(1):93-100. doi: 10.1016/j.ijcard.2011.01.033. Epub 2011 Feb 4. |
| 18301937 | Background | Sadiq Butt M, Tahir-Nadeem M, Khan MK, Shabir R, Butt MS. Oat: unique among the cereals. Eur J Nutr. 2008 Mar;47(2):68-79. doi: 10.1007/s00394-008-0698-7. Epub 2008 Feb 26. |
| 23922010 | Background | Camargo A, Meneses ME, Perez-Martinez P, Delgado-Lista J, Jimenez-Gomez Y, Cruz-Teno C, Tinahones FJ, Paniagua JA, Perez-Jimenez F, Roche HM, Malagon MM, Lopez-Miranda J. Dietary fat differentially influences the lipids storage on the adipose tissue in metabolic syndrome patients. Eur J Nutr. 2014;53(2):617-26. doi: 10.1007/s00394-013-0570-2. Epub 2013 Aug 7. |
| 21810288 | Background | Charlton KE, Tapsell LC, Batterham MJ, O'Shea J, Thorne R, Beck E, Tosh SM. Effect of 6 weeks' consumption of beta-glucan-rich oat products on cholesterol levels in mildly hypercholesterolaemic overweight adults. Br J Nutr. 2012 Apr;107(7):1037-47. doi: 10.1017/S0007114511003850. Epub 2011 Aug 3. |
| 15173412 | Background | Chen CY, Milbury PE, Kwak HK, Collins FW, Samuel P, Blumberg JB. Avenanthramides and phenolic acids from oats are bioavailable and act synergistically with vitamin C to enhance hamster and human LDL resistance to oxidation. J Nutr. 2004 Jun;134(6):1459-66. doi: 10.1093/jn/134.6.1459. |
| 18062932 | Background | Guo W, Wise ML, Collins FW, Meydani M. Avenanthramides, polyphenols from oats, inhibit IL-1beta-induced NF-kappaB activation in endothelial cells. Free Radic Biol Med. 2008 Feb 1;44(3):415-29. doi: 10.1016/j.freeradbiomed.2007.10.036. Epub 2007 Oct 22. |
| 10606548 | Background | Handelman GJ, Cao G, Walter MF, Nightingale ZD, Paul GL, Prior RL, Blumberg JB. Antioxidant capacity of oat (Avena sativa L.) extracts. 1. Inhibition of low-density lipoprotein oxidation and oxygen radical absorbance capacity. J Agric Food Chem. 1999 Dec;47(12):4888-93. doi: 10.1021/jf990529j. |
| 11976156 | Background | Jenkins DJ, Kendall CW, Vuksan V, Vidgen E, Parker T, Faulkner D, Mehling CC, Garsetti M, Testolin G, Cunnane SC, Ryan MA, Corey PN. Soluble fiber intake at a dose approved by the US Food and Drug Administration for a claim of health benefits: serum lipid risk factors for cardiovascular disease assessed in a randomized controlled crossover trial. Am J Clin Nutr. 2002 May;75(5):834-9. doi: 10.1093/ajcn/75.5.834. |
| 19090602 | Background | Jenkins AL, Jenkins DJ, Wolever TM, Rogovik AL, Jovanovski E, Bozikov V, Rahelic D, Vuksan V. Comparable postprandial glucose reductions with viscous fiber blend enriched biscuits in healthy subjects and patients with diabetes mellitus: acute randomized controlled clinical trial. Croat Med J. 2008 Dec;49(6):772-82. doi: 10.3325/cmj.2008.49.722. |
| 21862744 | Background | Jenkins DJ, Jones PJ, Lamarche B, Kendall CW, Faulkner D, Cermakova L, Gigleux I, Ramprasath V, de Souza R, Ireland C, Patel D, Srichaikul K, Abdulnour S, Bashyam B, Collier C, Hoshizaki S, Josse RG, Leiter LA, Connelly PW, Frohlich J. Effect of a dietary portfolio of cholesterol-lowering foods given at 2 levels of intensity of dietary advice on serum lipids in hyperlipidemia: a randomized controlled trial. JAMA. 2011 Aug 24;306(8):831-9. doi: 10.1001/jama.2011.1202. |
| 24814322 | Background | Kaestner R, Darden M, Lakdawalla D. Are investments in disease prevention complements? The case of statins and health behaviors. J Health Econ. 2014 Jul;36:151-63. doi: 10.1016/j.jhealeco.2014.04.006. Epub 2014 Apr 16. |
| 24655714 | Background | Kalantarian S, Rimm EB, Herrington DM, Mozaffarian D. Dietary macronutrients, genetic variation, and progression of coronary atherosclerosis among women. Am Heart J. 2014 Apr;167(4):627-635.e1. doi: 10.1016/j.ahj.2014.01.001. Epub 2014 Jan 15. |
| 22125193 | Background | Keaney JF Jr. Immune modulation of atherosclerosis. Circulation. 2011 Nov 29;124(22):e559-60. doi: 10.1161/CIRCULATIONAHA.111.074096. No abstract available. |
| 24911216 | Background | Lee DS, Markwardt S, Goeres L, Lee CG, Eckstrom E, Williams C, Fu R, Orwoll E, Cawthon PM, Stefanick ML, Mackey D, Bauer DC, Nielson CM. Statins and physical activity in older men: the osteoporotic fractures in men study. JAMA Intern Med. 2014 Aug;174(8):1263-70. doi: 10.1001/jamainternmed.2014.2266. |
| 20102847 | Background | Maki KC, Beiseigel JM, Jonnalagadda SS, Gugger CK, Reeves MS, Farmer MV, Kaden VN, Rains TM. Whole-grain ready-to-eat oat cereal, as part of a dietary program for weight loss, reduces low-density lipoprotein cholesterol in adults with overweight and obesity more than a dietary program including low-fiber control foods. J Am Diet Assoc. 2010 Feb;110(2):205-14. doi: 10.1016/j.jada.2009.10.037. |
| 23410611 | Background | Moodie R, Stuckler D, Monteiro C, Sheron N, Neal B, Thamarangsi T, Lincoln P, Casswell S; Lancet NCD Action Group. Profits and pandemics: prevention of harmful effects of tobacco, alcohol, and ultra-processed food and drink industries. Lancet. 2013 Feb 23;381(9867):670-9. doi: 10.1016/S0140-6736(12)62089-3. Epub 2013 Feb 12. |
| 16139284 | Background | Nie L, Wise ML, Peterson DM, Meydani M. Avenanthramide, a polyphenol from oats, inhibits vascular smooth muscle cell proliferation and enhances nitric oxide production. Atherosclerosis. 2006 Jun;186(2):260-6. doi: 10.1016/j.atherosclerosis.2005.07.027. Epub 2005 Sep 1. |
| 24793442 | Background | Rojas-Fernandez CH, Goldstein LB, Levey AI, Taylor BA, Bittner V, The National Lipid Association's Safety Task Force. An assessment by the Statin Cognitive Safety Task Force: 2014 update. J Clin Lipidol. 2014 May-Jun;8(3 Suppl):S5-16. doi: 10.1016/j.jacl.2014.02.013. |
| 22055990 | Background | Smith SC Jr, Benjamin EJ, Bonow RO, Braun LT, Creager MA, Franklin BA, Gibbons RJ, Grundy SM, Hiratzka LF, Jones DW, Lloyd-Jones DM, Minissian M, Mosca L, Peterson ED, Sacco RL, Spertus J, Stein JH, Taubert KA. AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation endorsed by the World Heart Federation and the Preventive Cardiovascular Nurses Association. J Am Coll Cardiol. 2011 Nov 29;58(23):2432-46. doi: 10.1016/j.jacc.2011.10.824. Epub 2011 Nov 3. No abstract available. |
| 22118569 | Background | Wolever TM, Gibbs AL, Brand-Miller J, Duncan AM, Hart V, Lamarche B, Tosh SM, Duss R. Bioactive oat beta-glucan reduces LDL cholesterol in Caucasians and non-Caucasians. Nutr J. 2011 Nov 25;10:130. doi: 10.1186/1475-2891-10-130. |
| 24799247 | Background | Yang J, Ou B, Wise ML, Chu Y. In vitro total antioxidant capacity and anti-inflammatory activity of three common oat-derived avenanthramides. Food Chem. 2014 Oct 1;160:338-45. doi: 10.1016/j.foodchem.2014.03.059. Epub 2014 Mar 21. |
| 22866937 | Background | Zhang J, Li L, Song P, Wang C, Man Q, Meng L, Cai J, Kurilich A. Randomized controlled trial of oatmeal consumption versus noodle consumption on blood lipids of urban Chinese adults with hypercholesterolemia. Nutr J. 2012 Aug 6;11:54. doi: 10.1186/1475-2891-11-54. |
| WORLD HEALTH ORGANIZATION. Prevention of cardiovascular disease: guidelines for assessment and management of total cardiovascular risk, 2007 | View source |