Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005514
Status:
COMPLETED
Last Update Posted:
2013-03-20
First Post:
2000-05-25
Brief Title:
Dietary Patterns and Risk of Cardiovascular Disease
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 121700 women age 30 to 55 years at baseline in 1976 the Nurses Health Study NHS and 51529 men aged 40-75 years at baseline in 1986 the Health Professionals Follow-up Study HPFS
Detailed 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 factorcluster analysis and dietary indexes were evaluated Further using prospectively collected and stored bloods in the NHS n-32826 during 1989-1990 and the HPFS n-18000 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 n121700 and Health Professionals Follow-up Study n51529 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
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 factorcluster analysis and dietary indexes were evaluated Further using prospectively collected and stored bloods in the NHS n-32826 during 1989-1990 and the HPFS n-18000 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 n121700 and Health Professionals Follow-up Study n51529 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL060712 | NIH | None | httpsreporternihgovquickSearchR01HL060712 |