June 20, 2016
NIH Desk Officer
Office of Information and Regulatory Affairs
Office of Management and Budget
Re: The Framingham Heart Study, 0925-0216, Revision
Dear Sir or Madam,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to submit comments to the The National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) regarding its April 22, 2016 information collection for the Framingham Heart Study, 0925-0216, Revision. Representing over 90,000 registered dietitian nutritionists (RDNs),1 nutrition dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals in the United States and is committed to improving the nation’s health through food and nutrition across the lifecycle. Academy members independently provide nutrition care services, including Medical Nutrition Therapy (MNT),2 to individuals with a wide variety of disease states and chronic conditions, including cardiovascular disease (CVD) and risk factors of CVD.
Since 1948, the Framingham Heart Study has been exhaustively researching the leading cause of death in the United States and making significant contributions to the literature. The Academy strongly supports this extension of the Framingham Heart Study to examine the Generation Three Cohort, New Offspring Spouses, and Omni Group 2 Cohort, as well as to continue to monitor the morbidity and mortality which occurs in all Framingham Cohorts.
CVD onset can often be prevented and disease progression can be slowed with lifestyle modifications, such as diet. The multi-generational aspect of the Framingham Heart Study and enhanced diversity provided by the Omni cohorts make it unmatched in scientific rigor and result, generating more than 1200 scientific journal articles, with many discoveries related to diet. The inclusion of spouses is significant and will beneficially increase the amount of data available.3 All study participants or their relatives have been closely examined previously, and thus the study deals with a stable, carefully described group.
As the Framingham Heart Study notes, "[o]ver the years, careful monitoring of the Framingham Study population has led to the identification of the major CVD risk factors—high blood pressure, high blood cholesterol, smoking and lung cancer, obesity, diabetes, and physical inactivity—as well as a great deal of valuable information on the effects of related factors such as blood triglyceride and HDL cholesterol levels, age, gender, and psychosocial issues."4 The Academy, however, believes that traditional CVD risk assessment measures should also include LDL-cholesterol. Thus, although LDL-cholesterol is not presently part of the Framingham Heart Study, it is widely recognized as a better marker of atherosclerotic risk than total- or HDL-cholesterol, and is certainly a part of "traditional" approach to assessing and monitoring risk and should be included.5 The study should also include nontraditional CVD risk assessment measures that are considered good quality biomarkers of risk of CVD (or that are related to its development) and that can be reasonably targeted by lifestyle changes in this review's target population of adults without known CVD.
The Academy also particularly supports extension of the examination of the Omni Group 2 Cohort. Researchers need to know more about why heart disease is particularly prevalent among certain ethnic and racial groups, the cultural factors at play, participants' dietary habits, environmental triggers or influences, preventive program possibilities, and a better understanding of influences across cultural and ethnic groups. Based on the new information and research arising from this extension, we eagerly anticipate learning more about the genetic factors influencing CVD.
The Academy appreciates the opportunity to comment on the information collection regarding the Framingham Heart Study. We would be grateful for the opportunity to discuss these recommendations in greater detail in the near future with you. Please contact either Jeanne Blankenship at 312-899-1730 or by email at email@example.com or Pepin Tuma at 202-775-8277 ext. 6001 or by email at firstname.lastname@example.org with any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 Medical Nutrition Therapy is an evidence-based application of the Nutrition Care Process. The provision of MNT (to a patient/client) may include one or more of the following: nutrition assessment/re-assessment, nutrition diagnosis, nutrition intervention, and nutrition monitoring and evaluation that typically results in the prevention, delay, or management of diseases and/or conditions.
3 See "Recent Framingham Research Related to Diet."
4 History of the Framingham Heart Study. Framingham Heart Study website. Accessed May 20, 2016.
5 Expert Dyslipidemia Panel of the International Atherosclerosis Society Panel members. An International Atherosclerosis Society Position Paper: Global Recommendations for the Management of Dyslipidemia—Full Report. J Clin Lipidol. 2014 Jan-Feb;8(1):29-60.
Buendia JR, Bradlee ML, Singer MR, Moore LL. Diets higher in protein predict lower high blood pressure risk in Framingham Offspring Study adults. Am J Hypertens. 2015;28(3):372-9. Epub 2014/09/07. doi: 10.1093/ajh/hpu157.
Cassidy A, Rogers G, Peterson JJ, Dwyer JT, Lin H, Jacques PF. Higher dietary anthocyanin and flavonol intakes are associated with anti-inflammatory effects in a population of US adults. Am J Clin Nutr. 2015. Epub 2015/05/29. doi: 10.3945/ajcn.115.108555.
Jacques PF, Cassidy A, Rogers G, Peterson JJ, Dwyer JT. Dietary flavonoid intakes and CVD incidence in the Framingham Offspring Cohort. Br J Nutr. 2015;114(9):1496-503. Epub 2015/09/04. doi: 10.1017/s0007114515003141.
Ma J, Fox CS, Jacques PF, Speliotes EK, Hoffmann U, Smith CE, Saltzman E, McKeown NM. Sugar-sweetened beverage, diet soda, and fatty liver disease in the Framingham Heart Study cohorts. Journal of hepatology. 2015. Epub 2015/06/10. doi: 10.1016/j.jhep.2015.03.032.
Ma J, McKeown NM, Hwang SJ, Hoffmann U, Jacques PF, Fox CS. Sugar-Sweetened Beverage Consumption Is Associated With Change of Visceral Adipose Tissue Over 6 Years of Follow-Up. Circulation. 2016;133(4):370-7. Epub 2016/01/13. doi: 10.1161/circulationaha.115.018704.
Mangano KM, Sahni S, Kiel DP, Tucker KL, Dufour AB, Hannan MT. Bone Mineral Density and Protein-Derived Food Clusters from the Framingham Offspring Study.Journal of the Academy of Nutrition and Dietetics. 2015;115(10):1605-13.e1. Epub 2015/06/04. doi: 10.1016/j.jand.2015.04.001.
Nettleton JA, Follis JL, Ngwa JS, Smith CE, Ahmad S, Tanaka T, Wojczynski MK, Voortman T, Lemaitre RN, Kristiansson K, Nuotio ML, Houston DK, Perala MM, Qi Q, Sonestedt E, Manichaikul A, Kanoni S, Ganna A, Mikkila V, North KE, Siscovick DS, Harald K, McKeown NM, Johansson I, Rissanen H, Liu Y, Lahti J, Hu FB, Bandinelli S, Rukh G, Rich S, Booij L, Dmitriou M, Ax E, Raitakari O, Mukamal K, Mannisto S, Hallmans G, Jula A, Ericson U, Jacobs DR, Jr., van Rooij FJ, Deloukas P, Sjogren P, Kahonen M, Djousse L, Perola M, Barroso I, Hofman A, Stirrups K, Viikari J, Uitterlinden AG, Kalafati IP, Franco OH, Mozaffarian D, Salomaa V, Borecki IB, Knekt P, Kritchevsky SB, Eriksson JG, Dedoussis GV, Qi L, Ferrucci L, Orho-Melander M, Zillikens MC, Ingelsson E, Lehtimaki T, Renstrom F, Cupples LA, Loos R, Franks PW. Gene x dietary pattern interactions in obesity: analysis of up to 68,317 adults of European ancestry. Hum Mol Genet. 2015. Epub 2015/05/23. doi: 10.1093/hmg/ddv186.
Sahni S, Mangano KM, McLean RR, Hannan MT, Kiel DP. Dietary Approaches for Bone Health: Lessons from the Framingham Osteoporosis Study. Current osteoporosis reports. 2015;13(4):245-55. Epub 2015/06/06. doi: 10.1007/s11914-015-0272-1.
Sauder KA, Proctor DN, Chow M, Troy LM, Wang N, Vita JA, Vasan RS, Mitchell GF, Jacques PF, Hamburg NM, West SG. Endothelial function, arterial stiffness and adherence to the 2010 Dietary Guidelines for Americans: a cross-sectional analysis. Br J Nutr. 2015:1-9. Epub 2015/04/18.
Wang H, Fox CS, Troy LM, McKeown NM, Jacques PF. Longitudinal association of dairy consumption with the changes in blood pressure and the risk of incident hypertension: the Framingham Heart Study. Br J Nutr. 2015;114(11):1887-99. Epub 2015/09/24. doi: 10.1017/s0007114515003578.