Cardiovascular DiseasesNCT00006500
Trends in Trans-Fatty Acid Intake Between 1980 and 1997
An observational study of Cardiovascular Diseases and Coronary Disease, run by University of Minnesota.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2000to Mar 2002
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To examine trends in trans-fatty acid intake by using newly available nutrient data to recalculate 24 dietary recalls from the Minnesota Heart Survey.
Read the 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.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2000 (estimated)
- Study startApr 2000
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Lisa Harnack, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006500
- Sponsor's protocol ID
- 941
- Other IDs
- R03HL064592
- Status last verified
- Jun 2016
- First submitted
- 16 Nov 2000
- Last updated
- 24 Jun 2016
- Results posted
- No
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. doi: 10.1016/s0002-8223(03)00976-3.
PubMed 12963944
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trends in Trans-Fatty Acid Intake Between 1980 and 1997
- ClinicalTrials.gov ID
- NCT00006500
- Acronym / sponsor ID
- 941
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2000
- Study completion
- Mar 2002
- First posted
- 17 Nov 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To examine trends in trans-fatty acid intake by using newly available nutrient data to recalculate 24 dietary recalls from the Minnesota Heart Survey.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Background: PubMed 12963944Harnack 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. doi: 10.1016/s0002-8223(03)00976-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Harnack
University of Minnesota
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006500, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.