Dietary Patterns and Risk of Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005514
• Other study ID #: 5032
• Secondary ID: R01HL060712
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: March 18, 2013
• Start date: August 1998
• Est. completion date: January 2009

Study information

• Verified date: March 2013
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To study, prospectively, the association between dietary patterns and risk of coronary heart disease (CHD), ischemic stroke, and hemorrhagic stroke in cohort studies of 121,700 women age 30 to 55 years at baseline in 1976 (the Nurses; Health Study; NHS) and 51,529 men aged 40-75 years at baseline in 1986 (the Health Professionals Follow-up Study; HPFS).

Description:

DESIGN NARRATIVE:

In the first five years of the study analyses were performed on food consumption data collected through semiquantitative food frequency questionnaires at baseline and during follow-up in the Nurses Health Study and Health Professionals Follow-up Study cohorts. Dietary patterns were derived from the food consumption data using factor analysis, cluster analysis, and dietary indexes (based on prevailing dietary recommendations). In addition, using existing datasets from dietary validation studies in sub-samples of the two cohorts, the reproducibility and validity of dietary patterns defined by factor/cluster analysis and dietary indexes were evaluated. Further, using prospectively collected and stored bloods in the NHS (n-32,826) during 1989-1990 and the HPFS (n-18,000) during 1993-1994, the investigators examined whether observed associations between dietary patterns and CHD were explained by (or mediated through) plasma biochemical measurements (including serum lipids, thrombotic factors, antioxidants, fasting insulin, and homocysteine levels) in a nested case-control design; and they assessed prospectively the relationship between dietary patterns and these biomarkers in the control samples.

The study was renewed in 2005 to apply novel statistical methods (such as confirmatory factor analysis and structural equation modeling) to validate various dietary patterns and examine their associations with risk of type 2 diabetes, cardiovascular disease and total mortality in two large ongoing cohort studies, the Nurses' Health Study (n=121,700) and Health Professionals' Follow-up Study (n=51,529). In addition to evaluating prevailing dietary recommendations, the study will also examine the role of the Mediterranean-type dietary pattern, the Dietary Approaches to Stop Hypertension (DASH) dietary pattern, and the Atkins-type diet in predicting health outcomes. Using repeated measurements of diet, the study will examine the impact of changes in eating patterns and diet quality over time on subsequent risk of diabetes, CVD, and total mortality. In addition, it will examine relationships between major dietary patterns and novel plasma biomarkers of inflammation and endothelial function and whether such relationships are mediated through obesity. Finally, the study will test interactions between dietary patterns and individual single nucleotide polymorphisms (SNPs) and haplotypes of several promising candidate genes in the inflammation and endothelial dysfunction pathway on risk of coronary heart disease, including PPARa, PPARy, Adiponectin (AdipoQ), PON1, IL-6, TNF-a, ICAM-1, VCAM-1, E-Selectin, NOS3, ACE gene, and angiotensinogen (ANG) genes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120000
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older
• Eligibility: no history of chronic diseases at baseline

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Accident
• Cerebrovascular Disorders
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (15)

Digranes A, Hardardottir H, Bottolfsen KL. Temafloxacin: in vitro comparison with five other antibacterial agents. Chemotherapy. 1991;37(2):98-105. — View Citation

Fung TT, Rimm EB, Spiegelman D, Rifai N, Tofler GH, Willett WC, Hu FB. Association between dietary patterns and plasma biomarkers of obesity and cardiovascular disease risk. Am J Clin Nutr. 2001 Jan;73(1):61-7. — View Citation

Fung TT, Stampfer MJ, Manson JE, Rexrode KM, Willett WC, Hu FB. Prospective study of major dietary patterns and stroke risk in women. Stroke. 2004 Sep;35(9):2014-9. Epub 2004 Jul 1. — View Citation

Fung TT, Willett WC, Stampfer MJ, Manson JE, Hu FB. Dietary patterns and the risk of coronary heart disease in women. Arch Intern Med. 2001 Aug 13-27;161(15):1857-62. — View Citation

Halton TL, Hu FB. The effects of high protein diets on thermogenesis, satiety and weight loss: a critical review. J Am Coll Nutr. 2004 Oct;23(5):373-85. Review. — View Citation

Hu FB, Rimm E, Smith-Warner SA, Feskanich D, Stampfer MJ, Ascherio A, Sampson L, Willett WC. Reproducibility and validity of dietary patterns assessed with a food-frequency questionnaire. Am J Clin Nutr. 1999 Feb;69(2):243-9. — View Citation

Hu FB, Rimm EB, Stampfer MJ, Ascherio A, Spiegelman D, Willett WC. Prospective study of major dietary patterns and risk of coronary heart disease in men. Am J Clin Nutr. 2000 Oct;72(4):912-21. — View Citation

Hu FB, Stampfer MJ, Manson JE, Grodstein F, Colditz GA, Speizer FE, Willett WC. Trends in the incidence of coronary heart disease and changes in diet and lifestyle in women. N Engl J Med. 2000 Aug 24;343(8):530-7. — View Citation

Hu FB, Willett WC. Optimal diets for prevention of coronary heart disease. JAMA. 2002 Nov 27;288(20):2569-78. Review. — View Citation

Hu FB. Plant-based foods and prevention of cardiovascular disease: an overview. Am J Clin Nutr. 2003 Sep;78(3 Suppl):544S-551S. Review. — View Citation

Hu FB. Protein, body weight, and cardiovascular health. Am J Clin Nutr. 2005 Jul;82(1 Suppl):242S-247S. Review. — View Citation

McCullough ML, Feskanich D, Stampfer MJ, Rosner BA, Hu FB, Hunter DJ, Variyam JN, Colditz GA, Willett WC. Adherence to the Dietary Guidelines for Americans and risk of major chronic disease in women. Am J Clin Nutr. 2000 Nov;72(5):1214-22. — View Citation

Osganian SK, Stampfer MJ, Rimm E, Spiegelman D, Hu FB, Manson JE, Willett WC. Vitamin C and risk of coronary heart disease in women. J Am Coll Cardiol. 2003 Jul 16;42(2):246-52. — View Citation

Osganian SK, Stampfer MJ, Rimm E, Spiegelman D, Manson JE, Willett WC. Dietary carotenoids and risk of coronary artery disease in women. Am J Clin Nutr. 2003 Jun;77(6):1390-9. — View Citation

Schulze MB, Hoffmann K, Manson JE, Willett WC, Meigs JB, Weikert C, Heidemann C, Colditz GA, Hu FB. Dietary pattern, inflammation, and incidence of type 2 diabetes in women. Am J Clin Nutr. 2005 Sep;82(3):675-84; quiz 714-5. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident cardiovascular disease	Myocardial infarction, fatal coronary disease, and stroke documented by medical records	1980-2008	No