Carb Quality and CHD in US Adults

Coronary Heart Disease Clinical Trial

Official title:

Carbohydrate Quality and Quantity and Risk of Coronary Heart Disease Among US Women and Men.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03214861
• Other study ID #: Carb Quality and CHD NHS HPFS
• Secondary ID: UM1CA186107UM1CA
• Status: Completed
• Phase: N/A
• First received: July 10, 2017
• Last updated: October 12, 2017
• Start date: June 1976
• Est. completion date: June 2012

Study information

• Verified date: July 2017
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an analysis conducted in the Nurses Health Study and the Health Professional Follow-Up Study, both prospective cohort studies, where the investigators systematically investigated the association between carbohydrate quality using a variety of metrics in relation to coronary heart disease. This was a secondary data analysis of previously collected data in both cohorts.

Description:

In this study, the investigators studied the association between carbohydrate quality and coronary heart disease using prospective cohort studies among US adults. Carbohydrate quality was evaluated using a variety of metrics including carbohydrate, starch, total fiber, cereal fiber, fruit fiber, and vegetable fiber intake, as well as the ratios of carbohydrate to total fiber, carbohydrate to cereal fiber, starch to total fiber, and starch to cereal fiber. The Nurses' Health Study (NHS) and the Health Professionals Follow Up Study (HPFS) started in 1984 and 1986, respectively, and were followed-up every 2-4 years thereafter until 2012. Participants include in this study had up to 28y of follow-up. All participants were free of known diabetes mellitus, cancer or cardiovascular disease at baseline. Cox proportional hazards regression models were used to assess the relationship between dietary measures of carbohydrate quality and incident CHD (nonfatal myocardial infarction and fatal CHD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117885
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants of these two cohorts

Exclusion Criteria:

• Participants with diabetes, coronary heart disease, or cancer at baseline

• Participants with missing exposure information at baseline

• Participants with implausible food frequency questionnaire info (females: kcal < 500 or > 3500; males: kcal < 800 or > 4200)

• Participants who left 10 or more items blank on the food frequency questionnaire

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Other:
• Carbohydrate quality
This is an observational study examining the association between carbohydrate quality and coronary heart disease. The investigators used a variety of carbohydrate quality metrics to evaluate carbohydrate quality including carbohydrate, starch, total fiber, cereal fiber, fruit fiber, and vegetable fiber intakes, and the ratios of carbohydrate to total fiber, carbohydrate to cereal fiber, starch to total fiber, and starch to cereal fiber intakes.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Harvard School of Public Health	Kuwait Foundation for the Advancement of Science, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

References & Publications (43)

Akesson A, Larsson SC, Discacciati A, Wolk A. Low-risk diet and lifestyle habits in the primary prevention of myocardial infarction in men: a population-based prospective cohort study. J Am Coll Cardiol. 2014 Sep 30;64(13):1299-306. doi: 10.1016/j.jacc.2014.06.1190. — View Citation

AlEssa HB, Bhupathiraju SN, Malik VS, Wedick NM, Campos H, Rosner B, Willett WC, Hu FB. Carbohydrate quality and quantity and risk of type 2 diabetes in US women. Am J Clin Nutr. 2015 Dec;102(6):1543-53. doi: 10.3945/ajcn.115.116558. Epub 2015 Nov 4. — View Citation

Barclay AW, Petocz P, McMillan-Price J, Flood VM, Prvan T, Mitchell P, Brand-Miller JC. Glycemic index, glycemic load, and chronic disease risk--a meta-analysis of observational studies. Am J Clin Nutr. 2008 Mar;87(3):627-37. Review. — View Citation

Ferrannini E, Buzzigoli G, Bonadonna R, Giorico MA, Oleggini M, Graziadei L, Pedrinelli R, Brandi L, Bevilacqua S. Insulin resistance in essential hypertension. N Engl J Med. 1987 Aug 6;317(6):350-7. — View Citation

Feskanich D, Rimm EB, Giovannucci EL, Colditz GA, Stampfer MJ, Litin LB, Willett WC. Reproducibility and validity of food intake measurements from a semiquantitative food frequency questionnaire. J Am Diet Assoc. 1993 Jul;93(7):790-6. — View Citation

Howarth NC, Saltzman E, Roberts SB. Dietary fiber and weight regulation. Nutr Rev. 2001 May;59(5):129-39. Review. — View Citation

Hu FB, Stampfer MJ, Rimm E, Ascherio A, Rosner BA, Spiegelman D, Willett WC. Dietary fat and coronary heart disease: a comparison of approaches for adjusting for total energy intake and modeling repeated dietary measurements. Am J Epidemiol. 1999 Mar 15;149(6):531-40. — View Citation

Huffman MD, Capewell S, Ning H, Shay CM, Ford ES, Lloyd-Jones DM. Cardiovascular health behavior and health factor changes (1988-2008) and projections to 2020: results from the National Health and Nutrition Examination Surveys. Circulation. 2012 May 29;125(21):2595-602. doi: 10.1161/CIRCULATIONAHA.111.070722. Epub 2012 Apr 30. — View Citation

Jenkins DJ, Wolever TM, Leeds AR, Gassull MA, Haisman P, Dilawari J, Goff DV, Metz GL, Alberti KG. Dietary fibres, fibre analogues, and glucose tolerance: importance of viscosity. Br Med J. 1978 May 27;1(6124):1392-4. — View Citation

Johnsen NF, Frederiksen K, Christensen J, Skeie G, Lund E, Landberg R, Johansson I, Nilsson LM, Halkjær J, Olsen A, Overvad K, Tjønneland A. Whole-grain products and whole-grain types are associated with lower all-cause and cause-specific mortality in the Scandinavian HELGA cohort. Br J Nutr. 2015 Aug 28;114(4):608-23. doi: 10.1017/S0007114515001701. Epub 2015 Jul 23. — View Citation

Jr. FEH. Regression Modeling Strategies: Applications to Linear Models, Logistic Regression, and Survival Analysis. New York, NY.: Springer-Verlag, 2001.

Juhan-Vague I, Alessi MC, Joly P, Thirion X, Vague P, Declerck PJ, Serradimigni A, Collen D. Plasma plasminogen activator inhibitor-1 in angina pectoris. Influence of plasma insulin and acute-phase response. Arteriosclerosis. 1989 May-Jun;9(3):362-7. — View Citation

Laws A, Reaven GM. Evidence for an independent relationship between insulin resistance and fasting plasma HDL-cholesterol, triglyceride and insulin concentrations. J Intern Med. 1992 Jan;231(1):25-30. — View Citation

Li Y, Hruby A, Bernstein AM, Ley SH, Wang DD, Chiuve SE, Sampson L, Rexrode KM, Rimm EB, Willett WC, Hu FB. Saturated Fats Compared With Unsaturated Fats and Sources of Carbohydrates in Relation to Risk of Coronary Heart Disease: A Prospective Cohort Study. J Am Coll Cardiol. 2015 Oct 6;66(14):1538-1548. doi: 10.1016/j.jacc.2015.07.055. — View Citation

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 Sep;70(3):412-9. — View Citation

Liu S, Willett WC, Stampfer MJ, Hu FB, Franz M, Sampson L, Hennekens CH, Manson JE. A prospective study of dietary glycemic load, carbohydrate intake, and risk of coronary heart disease in US women. Am J Clin Nutr. 2000 Jun;71(6):1455-61. — View Citation

Lloyd-Jones DM, Hong Y, Labarthe D, Mozaffarian D, Appel LJ, Van Horn L, Greenlund K, Daniels S, Nichol G, Tomaselli GF, Arnett DK, Fonarow GC, Ho PM, Lauer MS, Masoudi FA, Robertson RM, Roger V, Schwamm LH, Sorlie P, Yancy CW, Rosamond WD; American Heart Association Strategic Planning Task Force and Statistics Committee. Defining and setting national goals for cardiovascular health promotion and disease reduction: the American Heart Association's strategic Impact Goal through 2020 and beyond. Circulation. 2010 Feb 2;121(4):586-613. doi: 10.1161/CIRCULATIONAHA.109.192703. Epub 2010 Jan 20. Review. — View Citation

Long-Term Trends in Diagnosed Diabetes. CDC's Division of Diabetes Translation. National Diabetes Surveillance System. October 2011. http://www.cdc.gov/diabetes/statistics

Lutsey PL, Jacobs DR Jr, Kori S, Mayer-Davis E, Shea S, Steffen LM, Szklo M, Tracy R. Whole grain intake and its cross-sectional association with obesity, insulin resistance, inflammation, diabetes and subclinical CVD: The MESA Study. Br J Nutr. 2007 Aug;98(2):397-405. Epub 2007 Mar 29. — View Citation

McGuire S. U.S. Department of Agriculture and U.S. Department of Health and Human Services, Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, January 2011. Adv Nutr. 2011 May;2(3):293-4. doi: 10.3945/an.111.000430. Epub 2011 Apr 30. — View Citation

McKeown NM, Meigs JB, Liu S, Rogers G, Yoshida M, Saltzman E, Jacques PF. Dietary carbohydrates and cardiovascular disease risk factors in the Framingham offspring cohort. J Am Coll Nutr. 2009 Apr;28(2):150-8. — View Citation

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. Erratum in: Circulation. 2016 Feb 23;133(8):e417. Circulation. 2015 Jun 16;131(24):e535. — View Citation

Mozaffarian RS, Lee RM, Kennedy MA, Ludwig DS, Mozaffarian D, Gortmaker SL. Identifying whole grain foods: a comparison of different approaches for selecting more healthful whole grain products. Public Health Nutr. 2013 Dec;16(12):2255-64. doi: 10.1017/S1368980012005447. Epub 2013 Jan 4. — View Citation

Mozumdar A, Liguori G. Persistent increase of prevalence of metabolic syndrome among U.S. adults: NHANES III to NHANES 1999-2006. Diabetes Care. 2011 Jan;34(1):216-9. doi: 10.2337/dc10-0879. Epub 2010 Oct 1. — View Citation

Nutrient Data Laboratory (U.S.), Consumer and Food Economics Institute (U.S.), USDA nutrient database for standard reference. Riverdale, MD.: USDA Nutrient Data Laboratory, Agricultural Research Service, 1999:CD-ROMs.

Rebello SA, Koh H, Chen C, Naidoo N, Odegaard AO, Koh WP, Butler LM, Yuan JM, van Dam RM. Amount, type, and sources of carbohydrates in relation to ischemic heart disease mortality in a Chinese population: a prospective cohort study. Am J Clin Nutr. 2014 Jul;100(1):53-64. doi: 10.3945/ajcn.113.076273. Epub 2014 Apr 30. — View Citation

Rimm EB, Ascherio A, Giovannucci E, Spiegelman D, Stampfer MJ, Willett WC. Vegetable, fruit, and cereal fiber intake and risk of coronary heart disease among men. JAMA. 1996 Feb 14;275(6):447-51. — View Citation

Rimm EB, Giovannucci EL, Stampfer MJ, Colditz GA, Litin LB, Willett WC. Reproducibility and validity of an expanded self-administered semiquantitative food frequency questionnaire among male health professionals. Am J Epidemiol. 1992 May 15;135(10):1114-26; discussion 1127-36. — View Citation

Rose GA, Blackburn H. Cardiovascular survey methods. Monogr Ser World Health Organ. 1968;56:1-188. — View Citation

Salvini S, Hunter DJ, Sampson L, Stampfer MJ, Colditz GA, Rosner B, Willett WC. Food-based validation of a dietary questionnaire: the effects of week-to-week variation in food consumption. Int J Epidemiol. 1989 Dec;18(4):858-67. — View Citation

Siri-Tarino PW, Sun Q, Hu FB, Krauss RM. Meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease. Am J Clin Nutr. 2010 Mar;91(3):535-46. doi: 10.3945/ajcn.2009.27725. Epub 2010 Jan 13. — View Citation

Stampfer MJ, Hu FB, Manson JE, Rimm EB, Willett WC. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med. 2000 Jul 6;343(1):16-22. — View Citation

Tang G, Wang D, Long J, Yang F, Si L. Meta-analysis of the association between whole grain intake and coronary heart disease risk. Am J Cardiol. 2015 Mar 1;115(5):625-9. doi: 10.1016/j.amjcard.2014.12.015. Epub 2014 Dec 18. Review. — View Citation

U.S. Department of Agriculture and the U.S. Department of Health and Human Services. Nutrition and your health. Dietary guidelines for Americans. 1980.

Willett WC, Howe GR, Kushi LH. Adjustment for total energy intake in epidemiologic studies. Am J Clin Nutr. 1997 Apr;65(4 Suppl):1220S-1228S; discussion 1229S-1231S. Review. — View Citation

Willett WC, Sampson L, Stampfer MJ, Rosner B, Bain C, Witschi J, Hennekens CH, Speizer FE. Reproducibility and validity of a semiquantitative food frequency questionnaire. Am J Epidemiol. 1985 Jul;122(1):51-65. — View Citation

Willett WC. Nutritional Epidemiology. New York: Oxford University Press, 1998.

Wu H, Flint AJ, Qi Q, van Dam RM, Sampson LA, Rimm EB, Holmes MD, Willett WC, Hu FB, Sun Q. Association between dietary whole grain intake and risk of mortality: two large prospective studies in US men and women. JAMA Intern Med. 2015 Mar;175(3):373-84. doi: 10.1001/jamainternmed.2014.6283. — View Citation

Yang L, Colditz GA. Prevalence of Overweight and Obesity in the United States, 2007-2012. JAMA Intern Med. 2015 Aug;175(8):1412-3. doi: 10.1001/jamainternmed.2015.2405. — View Citation

Yang Q, Zhang Z, Gregg EW, Flanders WD, Merritt R, Hu FB. Added sugar intake and cardiovascular diseases mortality among US adults. JAMA Intern Med. 2014 Apr;174(4):516-24. doi: 10.1001/jamainternmed.2013.13563. — View Citation

Yang Y, Zhao LG, Wu QJ, Ma X, Xiang YB. Association between dietary fiber and lower risk of all-cause mortality: a meta-analysis of cohort studies. Am J Epidemiol. 2015 Jan 15;181(2):83-91. doi: 10.1093/aje/kwu257. Epub 2014 Dec 31. — View Citation

Yu D, Shu XO, Li H, Xiang YB, Yang G, Gao YT, Zheng W, Zhang X. Dietary carbohydrates, refined grains, glycemic load, and risk of coronary heart disease in Chinese adults. Am J Epidemiol. 2013 Nov 15;178(10):1542-9. doi: 10.1093/aje/kwt178. Epub 2013 Sep 5. — View Citation

Zong G, Gao A, Hu FB, Sun Q. Whole Grain Intake and Mortality From All Causes, Cardiovascular Disease, and Cancer: A Meta-Analysis of Prospective Cohort Studies. Circulation. 2016 Jun 14;133(24):2370-80. doi: 10.1161/CIRCULATIONAHA.115.021101. — View Citation

* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Heart Disease (CHD)	CHD includes both fatal and non-fatal myocardial infarction	June 1984 - June 2012