Cardiovascular DiseasesNCT00005257
Diet and Plasma Cholesterol - Secular Trend Analysis
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Coronary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 1990to Apr 1992
- 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 define the role of dietary variables on changes in plasma cholesterol levels over time in the Framingham cohort and the Framingham Offspring cohort.
Read the 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.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Coronary Disease, Hypercholesterolemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startMay 1990
- Study completionApr 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 National Heart, Lung, and Blood Institute (NHLBI)The 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
- Sponsor type
- US National Institutes of Health
- Investigators
- Barbara Posner, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005257
- Sponsor's protocol ID
- 1139
- Other IDs
- R01HL043919
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Campos H, Willett WC, Peterson RM, Siles X, Bailey SM, Wilson PW, Posner BM, Ordovas JM, Schaefer EJ. Nutrient intake comparisons between Framingham and rural and Urban Puriscal, Costa Rica. Associations with lipoproteins, apolipoproteins, and low density lipoprotein particle size. Arterioscler Thromb. 1991 Jul-Aug;11(4):1089-99. doi: 10.1161/01.atv.11.4.1089.
PubMed 2065030Posner BM, Franz MM, Quatromoni PA, Gagnon DR, Sytkowski PA, D'Agostino RB, Cupples LA. Secular trends in diet and risk factors for cardiovascular disease: the Framingham Study. J Am Diet Assoc. 1995 Feb;95(2):171-9. doi: 10.1016/S0002-8223(95)00043-7.
PubMed 7852683
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Plasma Cholesterol - Secular Trend Analysis
- ClinicalTrials.gov ID
- NCT00005257
- Acronym / sponsor ID
- 1139
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- May 1990
- Study completion
- Apr 1992 (actual)
- First posted
- 26 May 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 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.
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 13 May 2016.
- Background: PubMed 2065030Campos H, Willett WC, Peterson RM, Siles X, Bailey SM, Wilson PW, Posner BM, Ordovas JM, Schaefer EJ. Nutrient intake comparisons between Framingham and rural and Urban Puriscal, Costa Rica. Associations with lipoproteins, apolipoproteins, and low density lipoprotein particle size. Arterioscler Thromb. 1991 Jul-Aug;11(4):1089-99. doi: 10.1161/01.atv.11.4.1089.
- Background: PubMed 7852683Posner BM, Franz MM, Quatromoni PA, Gagnon DR, Sytkowski PA, D'Agostino RB, Cupples LA. Secular trends in diet and risk factors for cardiovascular disease: the Framingham Study. J Am Diet Assoc. 1995 Feb;95(2):171-9. doi: 10.1016/S0002-8223(95)00043-7.
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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.
Barbara Posner
Boston University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
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 13 May 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 NCT00005257, which also lists 2 linked publications.
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 13 May 2016.