Framingham Nutrition Studies

Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005513
• Other study ID #: 5031
• Secondary ID: R01HL060700
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: May 12, 2016
• Start date: September 1998
• Est. completion date: July 2002

Study information

• Verified date: August 2004
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To examine hypotheses concerning the relationships between nutrient intake (in particular, specific fatty acids, antioxidant nutrients, and B vitamins), dietary patterns, plasma lipoproteins, and heart disease endpoints in the population-based Framingham Offspring Studies.

Description:

DESIGN NARRATIVE:

Longitudinal analyses were conducted on the associations between diet and cardiovascular and cardiopulmonary disease risk in approximately 3,800 Offspring men and women over eight years of follow-up (from 1984 to present). These analyses considered key nutrients as well as newly defined dietary patterns in Framingham men and women. Cross sectional analyses of diet and plasma lipoprotein relationships in Offspring men and women at two examinations (Exam 3, 1984-88; and Exam 5, 1991-94) were also conducted. All analyses evaluated the total (direct and indirect) and joint effects of dietary nutrients. Where appropriate, analyses controlled for plasma nutrient levels (folacin, vitamins B6 and B12 and homocysteine). The influence of potential confounding variables, effect modifiers, and intervening variables that lie in the causal pathway were examined, as appropriate to the statistical model, including traditional cardiovascular disease risk factors and apoE isoform status.

Several existing Framingham data sets were utilized, including comprehensive data sets on nutrient intake, cardiovascular disease risk factors, clinically verified cardiovascular and cardiopulmonary endpoints and other covariates. The Offspring Exam 3 and 5 nutrition data sets included multiple day assessments of dietary intake which improved the ability to detect relationships of interest. The investigators completed the Framingham Food Habit Questionnaire data set for Exam 5; this instrument included important covariates for the analyses (including vitamin supplement use).

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (4)

Millen BE, Quatromoni PA, Copenhafer DL, Demissie S, O'Horo CE, D'Agostino RB. Validation of a dietary pattern approach for evaluating nutritional risk: the Framingham Nutrition Studies. J Am Diet Assoc. 2001 Feb;101(2):187-94. — View Citation

Millen BE, Quatromoni PA, Nam BH, O'Horo CE, Polak JF, D'Agostino RB. Dietary patterns and the odds of carotid atherosclerosis in women: the Framingham Nutrition Studies. Prev Med. 2002 Dec;35(6):540-7. — View Citation

Millen BE, Quatromoni PA. Nutritional research within the Framingham Heart Study. J Nutr Health Aging. 2001;5(3):139-43. Review. — View Citation

Quatromoni PA, Copenhafer DL, Demissie S, D'Agostino RB, O'Horo CE, Nam BH, Millen BE. The internal validity of a dietary pattern analysis. The Framingham Nutrition Studies. J Epidemiol Community Health. 2002 May;56(5):381-8. — View Citation