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Tracking Information | |||||
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First Received Date † | November 16, 2000 | ||||
Last Updated Date | June 23, 2005 | ||||
Start Date † | April 2000 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00006500 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Trends in Trans-Fatty Acid Intake Between 1980 and 1997 | ||||
Official Title † | |||||
Brief Summary | To examine trends in trans-fatty acid intake by using newly available nutrient data to recalculate 24 dietary recalls from the Minnesota Heart Survey. |
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Detailed Description | BACKGROUND: In recent years concern has arisen about the potential health hazards of trans-fatty acids in the American diet. Dietary intake of trans-fatty acids has been linked to unhealthy shifts in serum lipid profiles and to coronary heart disease (CHD) in a number of studies. Although several studies have estimated intakes of trans-fatty acids in U.S. populations, presently data is lacking regarding trends in intake of trans-fatty acids in the population. Furthermore, it is unclear how trends in intake of trans-fatty acids may be related to changes in other dietary and non-dietary CHD risk factors and CHD mortality. DESIGN NARRATIVE: The study used newly available nutrient data to recalculate dietary data collected as part of the Minnesota Heart Survey (MHS) to examine trends in intake of trans-fatty acids. The MHS was an ongoing observational epidemiologic study of trends in risk factors and cardiovascular morbidity and mortality among independent cross-sectional probability samples of the Minneapolis-St. Paul, Minnesota, metropolitan area. Surveys were conducted in 1980-1982, 1985-1987, 1990-1992 and 1995-1997. Diet was among the CVD risk factors measured as part of each survey. In this research, 24-hour dietary recalls collected from MHS participants were recalculated using an updated food and nutrient database that included trans-fatty acid values (16:1, 18:1, 18:2, and total). Intake estimates resulting from recalculation were analyzed to examine temporal trends in trans-fatty acid intake between 1980 and 1997, and to examine the relationship of temporal trends in trans-fatty acid intake to temporal changes in other dietary and non-dietary CHD risk factors and changes in CHD mortality. The MHS data provided a unique opportunity to examine a dietary constituent only recently recognized as a potential risk factor for CHD. |
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Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Natural History, Defined Population | ||||
Condition † |
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Intervention † | |||||
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Publications * | Harnack L, Lee S, Schakel SF, Duval S, Luepker RV, Arnett DK. Trends in the trans-fatty acid composition of the diet in a metropolitan area: the Minnesota Heart Survey. J Am Diet Assoc. 2003 Sep;103(9):1160-6. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | |||||
Completion Date | March 2002 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | No eligibility criteria |
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Gender | Male | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00006500 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | National Heart, Lung, and Blood Institute (NHLBI) | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||
Verification Date | April 2004 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |