AzTrials
AzTrials

Cardiovascular DiseasesNCT00005182

Health Professionals Follow-up Study

An observational study of Cardiovascular Diseases and Cerebrovascular Accident, run by Harvard School of Public Health (HSPH).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Any age, men only
How many people
50,000 participants
Where
No sites listed yet
Study dates
Dec 1985to May 2008
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 Any age
  • Men only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Male Health Professionals

Recruited through their professional organizations or occupation from mailing house lists.

About this study

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.

Read the 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 and/or 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 51,529 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 years.A subset of 18,225 participants provided blood samples between 1993 and 1995. Genotyping was performed among 435 cardiovascular disease cases and 878 controls using Affymetrix 6.0 platform.

Medical subject headings
Cardiovascular Diseases, Stroke, Coronary Disease, Peripheral Vascular Diseases, Heart Diseases, Myocardial Infarction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incident CVD

    Measured: Renewed every 5 years since 1986

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2000 (estimated)
  2. Study startDec 1985
  3. Primary completionMay 2008
  4. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005182
Sponsor's protocol ID
1060
Other IDs
R00HL088372
Status last verified
Feb 2018
First submitted
25 May 2000
Last updated
28 Feb 2018
Results posted
No

Publications

  • MacIntosh DL, Williams PL, Hunter DJ, Sampson LA, Morris SC, Willett WC, Rimm EB. Evaluation of a food frequency questionnaire-food composition approach for estimating dietary intake of inorganic arsenic and methylmercury. Cancer Epidemiol Biomarkers Prev. 1997 Dec;6(12):1043-50.

    PubMed 9419401

  • Giovannucci E, Rimm EB, Wolk A, Ascherio A, Stampfer MJ, Colditz GA, Willett WC. Calcium and fructose intake in relation to risk of prostate cancer. Cancer Res. 1998 Feb 1;58(3):442-7.

    PubMed 9458087

  • Welch G, Kawachi I, Barry MJ, Giovannucci E, Colditz GA, Willett WC. Distinction between symptoms of voiding and filling in benign prostatic hyperplasia: findings from the Health Professionals Follow-up Study. Urology. 1998 Mar;51(3):422-7. doi: 10.1016/s0090-4295(97)00626-2.

    PubMed 9510347

  • Madore F, Stampfer MJ, Rimm EB, Curhan GC. Nephrolithiasis and risk of hypertension. Am J Hypertens. 1998 Jan;11(1 Pt 1):46-53. doi: 10.1016/s0895-7061(97)00371-3.

    PubMed 9504449

  • Giovannucci E, Rimm EB, Stampfer MJ, Colditz GA, Willett WC. Diabetes mellitus and risk of prostate cancer (United States). Cancer Causes Control. 1998 Jan;9(1):3-9. doi: 10.1023/a:1008822917449.

    PubMed 9486458

  • Coakley EH, Rimm EB, Colditz G, Kawachi I, Willett W. Predictors of weight change in men: results from the Health Professionals Follow-up Study. Int J Obes Relat Metab Disord. 1998 Feb;22(2):89-96. doi: 10.1038/sj.ijo.0800549.

    PubMed 9504316

  • Aldoori WH, Giovannucci EL, Rockett HR, Sampson L, Rimm EB, Willett WC. A prospective study of dietary fiber types and symptomatic diverticular disease in men. J Nutr. 1998 Apr;128(4):714-9. doi: 10.1093/jn/128.4.714.

    PubMed 9521633

  • Aldoori WH, Giovannucci EL, Rimm EB, Wing AL, Willett WC. Use of acetaminophen and nonsteroidal anti-inflammatory drugs: a prospective study and the risk of symptomatic diverticular disease in men. Arch Fam Med. 1998 May-Jun;7(3):255-60. doi: 10.1001/archfami.7.3.255.

    PubMed 9596460

  • Rosner B, Willett WC. Interval estimates for correlation coefficients corrected for within-person variation: implications for study design and hypothesis testing. Am J Epidemiol. 1988 Feb;127(2):377-86. doi: 10.1093/oxfordjournals.aje.a114811.

    PubMed 3337089

  • Rimm EB, Stampfer MJ, Colditz GA, Giovannucci E, Willett WC. Effectiveness of various mailing strategies among nonrespondents in a prospective cohort study. Am J Epidemiol. 1990 Jun;131(6):1068-71. doi: 10.1093/oxfordjournals.aje.a115598.

    PubMed 2343859

  • Hunter DJ, Rimm EB, Sacks FM, Stampfer MJ, Colditz GA, Litin LB, Willett WC. Comparison of measures of fatty acid intake by subcutaneous fat aspirate, food frequency questionnaire, and diet records in a free-living population of US men. Am J Epidemiol. 1992 Feb 15;135(4):418-27. doi: 10.1093/oxfordjournals.aje.a116302.

    PubMed 1550093

  • Rimm EB, Giovannucci EL, Willett WC, Colditz GA, Ascherio A, Rosner B, Stampfer MJ. Prospective study of alcohol consumption and risk of coronary disease in men. Lancet. 1991 Aug 24;338(8765):464-8. doi: 10.1016/0140-6736(91)90542-w.

    PubMed 1678444

  • Ascherio A, Stampfer MJ, Colditz GA, Willett WC, McKinlay J. Nutrient intakes and blood pressure in normotensive males. Int J Epidemiol. 1991 Dec;20(4):886-91. doi: 10.1093/ije/20.4.886.

    PubMed 1666065

  • Giovannucci E, Colditz G, Stampfer MJ, Rimm EB, Litin L, Sampson L, Willett WC. The assessment of alcohol consumption by a simple self-administered questionnaire. Am J Epidemiol. 1991 Apr 15;133(8):810-7. doi: 10.1093/oxfordjournals.aje.a115960.

    PubMed 2021148

  • Colditz GA, Rimm EB, Giovannucci E, Stampfer MJ, Rosner B, Willett WC. A prospective study of parental history of myocardial infarction and coronary artery disease in men. Am J Cardiol. 1991 May 1;67(11):933-8. doi: 10.1016/0002-9149(91)90163-f.

    PubMed 2018010

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Cerebrovascular Accident, run by Harvard School of Public Health (HSPH).

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2018. 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.

What does the primary outcome measure?

Incident CVD (time frame: Renewed every 5 years since 1986). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00005182, which also lists 163 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 28 Feb 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in