Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005182
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2000-05-25
Brief Title:
Health Professionals Follow-up Study
Sponsor:
Harvard School of Public Health HSPH
Organization:
Harvard School of Public Health HSPH
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2018-02
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 test the hypothesis that increased risk of coronary heart disease stroke peripheral vascular disease and cancer is related to diets high in saturated fat animal protein and hydrogenated vegetable oil and low in polyunsaturated fat fiber vitamins A C and E calcium selenium and chromium
Detailed Description:
BACKGROUND
The diet-heart hypothesis that high dietary saturated fat and cholesterol intake increase the risk and high polyunsaturated fat reduces the risk of coronary heart disease in man is supported by ecologic studies by experiments in rodents and non-human primates by voluminous literature relating dietary factors to serum lipids by several secondary prevention trials and by the Lipid Research Clinics Trial demonstrating a reduction in coronary heart disease among participants assigned to cholestyramine
Despite the substantial scientific interest and the obvious public health implications of the diet and heart disease issue relatively few observational cohort or case-control investigations had been published prior to 1985 Although these observational studies were not entirely consistent taken collectively they tended to provide important general support for the diet-heart hypothesis However due to study design limited numbers of endpoints or methods of analysis many central questions remained unanswered The most important issue was the quantitative relationship between specific dietary factors and risk of coronary heart disease Moreover the interplay of dietary and genetic factors is poorly understood
DESIGN NARRATIVE
In this prospective cohort study participants completed a mailed general medical and health questionnaire at baseline and an intensively validated semiquantitative food frequency questionnaire SFFQ At one year tissue specimens were collected and catalogued for future nested case-control analyses of coronary heart disease risk in relation to levels of calcium selenium and chromium Follow-up questionnaires to update exposure information and ascertain non-fatal endpoints were mailed at two-year intervals All reported cases of non-fatal myocardial infarction stroke and cancer were documented with hospital records andor pathology reports Fatal events were ascertained with the National Death Index and documented To standardize SFFQ nutrient scores against measurements of absolute intake two one-week diet records were obtained from a random sample of 150 Boston-area participants
The study was renewed in 1991 1997 and in 2003 to continue the follow-up of 51529 male health professionals The cohort is followed by questionnaires mailed at two-year intervals to update exposure information and ascertain nonfatal events Complete dietary assessments are included every four yearsA subset of 18225 participants provided blood samples between 1993 and 1995 Genotyping was performed among 435 cardiovascular disease cases and 878 controls using Affymetrix 60 platform
The diet-heart hypothesis that high dietary saturated fat and cholesterol intake increase the risk and high polyunsaturated fat reduces the risk of coronary heart disease in man is supported by ecologic studies by experiments in rodents and non-human primates by voluminous literature relating dietary factors to serum lipids by several secondary prevention trials and by the Lipid Research Clinics Trial demonstrating a reduction in coronary heart disease among participants assigned to cholestyramine
Despite the substantial scientific interest and the obvious public health implications of the diet and heart disease issue relatively few observational cohort or case-control investigations had been published prior to 1985 Although these observational studies were not entirely consistent taken collectively they tended to provide important general support for the diet-heart hypothesis However due to study design limited numbers of endpoints or methods of analysis many central questions remained unanswered The most important issue was the quantitative relationship between specific dietary factors and risk of coronary heart disease Moreover the interplay of dietary and genetic factors is poorly understood
DESIGN NARRATIVE
In this prospective cohort study participants completed a mailed general medical and health questionnaire at baseline and an intensively validated semiquantitative food frequency questionnaire SFFQ At one year tissue specimens were collected and catalogued for future nested case-control analyses of coronary heart disease risk in relation to levels of calcium selenium and chromium Follow-up questionnaires to update exposure information and ascertain non-fatal endpoints were mailed at two-year intervals All reported cases of non-fatal myocardial infarction stroke and cancer were documented with hospital records andor pathology reports Fatal events were ascertained with the National Death Index and documented To standardize SFFQ nutrient scores against measurements of absolute intake two one-week diet records were obtained from a random sample of 150 Boston-area participants
The study was renewed in 1991 1997 and in 2003 to continue the follow-up of 51529 male health professionals The cohort is followed by questionnaires mailed at two-year intervals to update exposure information and ascertain nonfatal events Complete dietary assessments are included every four yearsA subset of 18225 participants provided blood samples between 1993 and 1995 Genotyping was performed among 435 cardiovascular disease cases and 878 controls using Affymetrix 60 platform
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 |
|---|---|---|---|
| R00HL088372 | NIH | None | httpsreporternihgovquickSearchR00HL088372 |