Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-29 @ 2:52 PM
Study NCT ID:
NCT00005257
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diet and Plasma Cholesterol - Secular Trend Analysis
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
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 define the role of dietary variables on changes in plasma cholesterol levels over time in the Framingham cohort and the Framingham Offspring cohort.
Detailed Description:
BACKGROUND:
Mortality from coronary heart disease has declined over 40 percent since the late 1960s. Possible explanations for the decline include the observed trends in risk factors such as changes in rates of hypertension, dyslipidemia, and glucose intolerance; lifestyle changes such as improvements in diet and decreases in the levels of cigarette smoking; and better detection and treatment of heart disease. The specific effects of risk factor, lifestyle, or detection and treatment changes on the declining population rates of coronary heart disease morbidity and mortality were unknown in 1990. Secular trend analyses were needed to elucidate the relative contribution of these factors, particularly dietary variables, on population rates of coronary heart disease.
DESIGN NARRATIVE:
Multiple regression was used to assess the effect of dietary variables on changes in serum cholesterol between 1957-1960 and 1966-1969 in a sample of 200 men for whom repeated measurements existed in the Framingham cohort. Analysis of covariance was used to assess influence of dietary intake on differences in serum cholesterol levels between independent samples of men studied in 1957-1960 and 1966-1969 in the Framingham cohort, and independent samples of women studied between 1957-1960 and 1984-1988 in the Framingham cohort and Offspring cohort, and independent samples of men studied between 1966-1969 and 1984-1988 in the Framingham cohort and Offspring cohorts respectively.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Mortality from coronary heart disease has declined over 40 percent since the late 1960s. Possible explanations for the decline include the observed trends in risk factors such as changes in rates of hypertension, dyslipidemia, and glucose intolerance; lifestyle changes such as improvements in diet and decreases in the levels of cigarette smoking; and better detection and treatment of heart disease. The specific effects of risk factor, lifestyle, or detection and treatment changes on the declining population rates of coronary heart disease morbidity and mortality were unknown in 1990. Secular trend analyses were needed to elucidate the relative contribution of these factors, particularly dietary variables, on population rates of coronary heart disease.
DESIGN NARRATIVE:
Multiple regression was used to assess the effect of dietary variables on changes in serum cholesterol between 1957-1960 and 1966-1969 in a sample of 200 men for whom repeated measurements existed in the Framingham cohort. Analysis of covariance was used to assess influence of dietary intake on differences in serum cholesterol levels between independent samples of men studied in 1957-1960 and 1966-1969 in the Framingham cohort, and independent samples of women studied between 1957-1960 and 1984-1988 in the Framingham cohort and Offspring cohort, and independent samples of men studied between 1966-1969 and 1984-1988 in the Framingham cohort and Offspring cohorts respectively.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL043919 | NIH | None | https://reporter.nih.gov/quic… | View |