Applying the FDA definition of whole grains to the evidence for cardiovascular disease health claims

Journal of Nutrition

Volumn 139, Issue 11, 2009, Pages

  De Moura, Fabiana F ^a   Lewis, Kara D ^a   Falk, Michael C ^a  

^a Life Sciences Research Office   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CARDIOVASCULAR DISEASE; CARDIOVASCULAR RISK; FOOD AND DRUG ADMINISTRATION; FOOD INTAKE; GRAIN; HUMAN; HYPERCHOLESTEROLEMIA; NUTRIENT CONTENT; RISK REDUCTION;

CARDIOVASCULAR DISEASES; CEREALS; DIET; DIET SURVEYS; FOOD HABITS; FOOD INDUSTRY; HEALTH PROMOTION; HUMANS; PUBLIC HEALTH; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 70350330873     PISSN: 00223166     EISSN: 15416100     Source Type: Journal    
DOI: 10.3945/jn.109.112383     Document Type: Article

References (53)

1. Nutrition Labeling and Education Act of 1990, Pub. L. No.101-535, U.S. Congress (Nov 8 1990).
2. U.S. Congress. Pub. L. No.105-115. Food and Drug Administration Modernization Act of 1997. FDA; 1997 [cited 2008 Jun 20]. Available from: http://www.fda.gov/CDER/guidance/105-115.htm.
3. U.S. FDA. Guidance to industry: notification of a health claim or nutrient content claim based on an authoritative statement of a scientific body. FDA; 1998 [cited 2008 Jun 5]. Available from: http://www.cfsan.fda.gov/~dms/ hclmguid.html.
4. U.S. FDA. Guidance for industry and FDA staff: whole grain label statements [draft guidance]. FDA; 2006 [cited 2008 May 30]. Available from: http://www.cfsan.fda.gov/~dms/flgragui.html.
5. U.S. FDA. Qualified health claims. FDA; 2006 [cited 2009 Mar 20]. Available from: http://www.cfsan.fda.gov/~dms/lab-qhc.html.
6. U.S. Code of Federal Regulations. 21 CFR § 101.76 Health claims: fiber-containing grain products, fruits, and vegetables and cancer. 2001 [cited 2008 Jun 16]. Available from: http://edocket.access.gpo.gov/cfr-2001/aprqtr/pdf/ 21cfr101.76.pdf.
7. U.S. Code of Federal Regulations. 21 CFR § 101.81 Health claims: soluble fiber from certain foods and risk of coronary heart disease (CHD). 2001 [cited 2008 Jun 16]. Available from: http://edocket.access.gpo.gov/cfr-2001/ aprqtr/pdf/21cfr101.81.pdf.
8. U.S. Code of Federal Regulations. 21 CFR §101.77 Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. 2001 [cited 2008 Jun 16]. Available from: http://edocket.access.gpo.gov/cfr-2001/aprqtr/pdf/21cfr101.77.pdf.
9. NRC. Diet and health: implications for reducing chronic disease risk. Washington, DC: National Academies Press; 1989.
10. Life Sciences Research Office. Whole grain intake and cardiovascular disease and whole grain intake and diabetes. A review. Bethesda (MD): Life Sciences Research Office; 2008.
11. USDA. Composition of foods raw, processed, prepared USDA national nutrient database for standard reference, release 20. 2008 [cited 2008 Jun 2]. Available from: http://www.nal.usda.gov/fnic/foodcomp/Data/SR20/SR20-doc.pdf
12. Adlercreutz H, Mazur W. Phyto-oestrogens and Western diseases. Ann Med. 1997;29:95-120.
13. Nilsson M, Åman P, Härkönen H, Hallmans G, Knudsen KEB, Mazur W, Adlercreutz H. Content of nutrients and lignans in roller milled fractions of rye. J Sci Food Agric. 1997;73:143-148 (Pubitemid 27144461)
14. Adom KK, Liu RH. Antioxidant activity of grains. J Agric Food Chem. 2002;50:6182-6187
15. Andreasen MF, Christensen LP, Meyer AS, Hansen A. Content of phenolic acids and ferulic acid dehydrodimers in 17 rye (Secale cereale L.) varieties. J Agric Food Chem. 2000;48:2837-2842 (Pubitemid 30490499)
16. Andreasen MF, Kroon PA, Williamson G, Garcia-Conesa MT. Esterase activity able to hydrolyze dietary antioxidant hydroxycinnamates is distributed along the intestine of mammals. J Agric Food Chem. 2001;49:5679-5684 (Pubitemid 33089725)
17. Zupfer JM, Churchill KE, Rasmusson DC, Fulcher RG. Variation in ferulic acid concentration among diverse barley cultivars measured by HPLC and microspectrophotometry. J Agric Food Chem. 1998;46:1350-1354
18. Bryngelsson S, Dimberg LH, Kamal-Eldin A. Effects of commercial processing on levels of antioxidants in oats (Avena sativa L.). J Agric Food Chem. 2002;50:1890-1896 (Pubitemid 34259984)
19. Ross AB, Shepherd MJ, Schupphaus M, Sinclair V, Alfaro B, Kamal-Eldin A, Åman P. Alkylresorcinols in cereals and cereal products. J Agric Food Chem. 2003;51:4111-4118
20. Chen Y, Ross AB, Åman P, Kamal-Eldin A. Alkylresorcinols as markers of whole grain wheat and rye in cereal products. J Agric Food Chem. 2004;52:8242-8246 (Pubitemid 40053721)
21. Piironen V, Toivo J, Lampi A-M. Plant sterols in cereals and cereal products. Cereal Chem. 2002;79:148-154 (Pubitemid 34044130)
22. U.S. FDA. Guidance for industry: evidence-based review system for the scientific evaluation of health claims [draft guidance]. 2007 [cited 2008 Mar 3]. Available from: http://www.cfsan.fda.gov/~dms/hclmgui5.html.
23. Jensen MK, Koh-Banerjee P, Hu FB, Franz M, Sampson L, Gronbaek M, Rimm EB. Intakes of whole grains, bran, and germ and the risk of coronary heart disease in men. Am J Clin Nutr. 2004;80:1492-1499 (Pubitemid 41103845)
24. Jensen MK, Koh-Banerjee P, Franz M, Sampson L, Gronbaek M, Rimm EB. Whole grains, bran, and germ in relation to homocysteine and markers of glycemic control, lipids, and inflammation. Am J Clin Nutr. 2006;83:275-283 (Pubitemid 44713187)
25. Andersson A, Tengblad S, Karlstrom B, Kamal-Eldin A, Landberg R, Basu S, Aman P, Vessby B. Whole-grain foods do not affect insulin sensitivity or markers of lipid peroxidation and inflammation in healthy, moderately overweight subjects. J Nutr. 2007;137:1401-1407 (Pubitemid 46855477)
26. Rave K, Roggen K, Dellweg S, Heise T, Tom DH. Improvement of insulin resistance after diet with a whole-grain based dietary product: results of a randomized, controlled cross-over study in obese subjects with elevated fasting blood glucose. Br J Nutr. 2007;98:1-8. (Pubitemid 47543450)
27. Jacobs DR Jr, Meyer KA, Kushi LH, Folsom AR. Whole-grain intake may reduce the risk of ischemic heart disease death in postmenopausal women: the Iowa Women's Health Study. Am J Clin Nutr. 1998;68:248-257
28. Esmaillzadeh A, Mirmiran P, Azizi F. Whole-grain consumption and the metabolic syndrome: a favorable association in Tehranian adults. Eur J Clin Nutr. 2005;59:353-362 (Pubitemid 40403288)
29. Jacobs DR Jr, Meyer KA, Kushi LH, Folsom AR. Is whole grain intake associated with reduced total and cause-specific death rates in older women? The Iowa Women's Health Study. Am J Public Health. 1999;89:322-329
30. Liu S, Stampfer MJ, Hu FB, Giovannucci E, Rimm E, Manson JE, Hennekens CH, Willett WC. Whole-grain consumption and risk of coronary heart disease: results from the nurses' health study. Am J Clin Nutr. 1999;70:412-419 (Pubitemid 29407162)
31. Liu S, Sesso HD, Manson JE, Willett WC, Buring JE. Is intake of breakfast cereals related to total and cause-specific mortality in men? Am J Clin Nutr. 2003;77:594-599
32. Liu S, Manson JE, Stampfer MJ, Rexrode KM, Hu FB, Rimm EB, Willett WC. Whole grain consumption and risk of ischemic stroke in women: a prospective study. JAMA. 2000;284:1534-1540 (Pubitemid 30767442)
33. McKeown NM, Meigs JB, Liu S, Wilson PW, Jacques PF. Whole-grain intake is favorably associated with metabolic risk factors for type 2 diabetes and cardiovascular disease in the Framingham Offspring Study. Am J Clin Nutr. 2002;76:390-398 (Pubitemid 34804062)
34. Newby PK, Maras J, Bakun P, Muller D, Ferrucci L, Tucker KL. Intake of whole grains, refined grains, and cereal fiber measured with 7-d diet records and associations with risk factors for chronic disease. Am J Clin Nutr. 2007;86:1745-1753 (Pubitemid 350232192)
35. Steffen LM, Jacobs DR Jr, Stevens J, Shahar E, Carithers T, Folsom AR. Associations of whole-grain, refined-grain, and fruit and vegetable consumption with risks of all-cause mortality and incident coronary artery disease and ischemic stroke: the Atherosclerosis Risk in Communities (ARIC) Study. Am J Clin Nutr. 2003;78:383-390 (Pubitemid 39663503)
36. Wang L, Gaziano JM, Liu S, Manson JE, Buring JE, Sesso HD. Whole- and refined-grain intakes and the risk of hypertension in women. Am J Clin Nutr. 2007;86:472-479 (Pubitemid 47256934)
37. Fraser GE, Sabate J, Beeson WL, Strahan TM. A possible protective effect of nut consumption on risk of coronary heart disease: The Adventist Health Study. Arch Intern Med. 1992;152:1416-1424
38. Fraser GE. Associations between diet and cancer, ischemic heart disease, and all-cause mortality in non-Hispanic white California Seventh-day Adventists. Am J Clin Nutr. 1999;70:S532-8.
39. He J, Klag MJ, Whelton PK, Mo JP, Chen JY, Qian MC, Mo PS, He GQ. Oats and buckwheat intakes and cardiovascular disease risk factors in an ethnic minority of China. Am J Clin Nutr. 1995;61:366-372
40. Davidson MH, Dugan LD, Burns JH, Bova J, Story K, Drennan KB. The hypocholesterolemic effects of beta-glucan in oatmeal and oat bran: a dose-controlled study. JAMA. 1991;265:1833-1839
41. Keenan JM, Pins JJ, Frazel C, Moran A, Turnquist L. Oat ingestion reduces systolic and diastolic blood pressure in patients with mild or borderline hypertension: a pilot trial. J Fam Pract. 2002;51:369.
42. Saltzman E, Das SK, Lichtenstein AH, Dallal GE, Corrales A, Schaefer EJ, Greenberg AS, Roberts SB. An oat-containing hypocaloric diet reduces systolic blood pressure and improves lipid profile beyond effects of weight loss in men and women. J Nutr. 2001;131:1465-1470 (Pubitemid 32422968)
43. Van Horn L, Emidy LA, Liu KA, Liao YL, Ballew C, King J, Stamler J. Serum lipid response to a fat-modified, oatmeal-enhanced diet. Prev Med. 1988;17:377-386 (Pubitemid 18183071)
44. Van Horn L, Moag-Stahlberg A, Liu KA, Ballew C, Ruth K, Hughes R, Stamler J. Effects on serum lipids of adding instant oats to usual American diets. Am J Public Health. 1991;81:183-188
45. Van Horn LV, Liu K, Parker D, Emidy L, Liao YL, Pan WH, Giumetti D, Hewitt J, Stamler J. Serum lipid response to oat product intake with a fat-modified diet. J Am Diet Assoc. 1986;86:759-764 (Pubitemid 16071161)
46. Judd PA, Truswell AS. The effect of rolled oats on blood lipids and fecal steroid excretion in man. Am J Clin Nutr. 1981;34:2061-2067
47. Behall KM, Scholfield DJ, Hallfrisch J. Diets containing barley significantly reduce lipids in mildly hypercholesterolemic men and women. Am J Clin Nutr. 2004;80:1185-1193 (Pubitemid 41350677)
48. Behall KM, Scholfield DJ, Hallfrisch J. Lipids significantly reduced by diets containing barley in moderately hypercholesterolemic men. J Am Coll Nutr. 2004;23:55-62. (Pubitemid 38200835)
49. Behall KM, Scholfield DJ, Hallfrisch J. Whole-grain diets reduce blood pressure in mildly hypercholesterolemic men and women. J Am Diet Assoc. 2006;106:1445-1449 (Pubitemid 44331741)
50. Li J, Kaneko T, Qin LQ, Wang J, Wang Y. Effects of barley intake on glucose tolerance, lipid metabolism, and bowel function in women. Nutrition. 2003;19:926-929 (Pubitemid 37421197)
51. Davy BM, Melby CL, Beske SD, Ho RC, Davrath LR, Davy KP. Oat consumption does not affect resting casual and ambulatory 24-h arterial blood pressure in men with high-normal blood pressure to stage I hypertension. J Nutr. 2002;132:394-398
52. Hallfrisch J, Scholfield DJ, Behall KM. Blood pressure reduced by whole grain diet containing barley or whole wheat and brown rice in moderately hypercholesterolemic men. Nutr Res. 2003;23:1631-1642 (Pubitemid 38018616)
53. U.S. FDA. Food labeling: health claims. Souluble fiber from certain foods and risk of coronary heart disease. Fed Regist. 2008;73:47828-47829