Carb Quality and CHD in US Adults

October 12, 2017 updated by: Hala Alessa, Harvard School of Public Health (HSPH)

Carbohydrate Quality and Quantity and Risk of Coronary Heart Disease Among US Women and Men.

This is an analysis conducted in the Nurses Health Study and the Health Professional Follow-Up Study, both prospective cohort studies, where the investigators systematically investigated the association between carbohydrate quality using a variety of metrics in relation to coronary heart disease. This was a secondary data analysis of previously collected data in both cohorts.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the investigators studied the association between carbohydrate quality and coronary heart disease using prospective cohort studies among US adults. Carbohydrate quality was evaluated using a variety of metrics including carbohydrate, starch, total fiber, cereal fiber, fruit fiber, and vegetable fiber intake, as well as the ratios of carbohydrate to total fiber, carbohydrate to cereal fiber, starch to total fiber, and starch to cereal fiber. The Nurses' Health Study (NHS) and the Health Professionals Follow Up Study (HPFS) started in 1984 and 1986, respectively, and were followed-up every 2-4 years thereafter until 2012. Participants include in this study had up to 28y of follow-up. All participants were free of known diabetes mellitus, cancer or cardiovascular disease at baseline. Cox proportional hazards regression models were used to assess the relationship between dietary measures of carbohydrate quality and incident CHD (nonfatal myocardial infarction and fatal CHD).

Study Type

Observational

Enrollment (Actual)

117885

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The Nurses' Health Study (NHS) was initiated in 1976 as a prospective cohort study, where 121,701 female registered nurses between the ages of 30 and 55 years were recruited from 11 US states. The Health Professionals Follow-up Study (HPFS) was initiated in 1986 and recruited 51,529 US men between the ages of 40-75. Every two years, participants updated their information on medical history, lifestyle, and incidence of chronic diseases using validated questionnaires. Follow-up rates are at least 90% of potential person-years of follow-up and mortality follow-up is more than 98%.

Description

Inclusion Criteria:

  • Participants of these two cohorts

Exclusion Criteria:

  • Participants with diabetes, coronary heart disease, or cancer at baseline
  • Participants with missing exposure information at baseline
  • Participants with implausible food frequency questionnaire info (females: kcal < 500 or > 3500; males: kcal < 800 or > 4200)
  • Participants who left 10 or more items blank on the food frequency questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Nurses Health Study
The Nurses' Health Study (NHS) was initiated in 1976 as a prospective cohort study, where 121,701 female registered nurses between the ages of 30 and 55 years were recruited from 11 US states.
Other: Carbohydrate quality
This is an observational study examining the association between carbohydrate quality and coronary heart disease. The investigators used a variety of carbohydrate quality metrics to evaluate carbohydrate quality including carbohydrate, starch, total fiber, cereal fiber, fruit fiber, and vegetable fiber intakes, and the ratios of carbohydrate to total fiber, carbohydrate to cereal fiber, starch to total fiber, and starch to cereal fiber intakes.
Health Professionals Follow-Up Study
The Health Professionals Follow-up Study (HPFS) was initiated in 1986 and recruited 51,529 US men between the ages of 40-75.
Other: Carbohydrate quality
This is an observational study examining the association between carbohydrate quality and coronary heart disease. The investigators used a variety of carbohydrate quality metrics to evaluate carbohydrate quality including carbohydrate, starch, total fiber, cereal fiber, fruit fiber, and vegetable fiber intakes, and the ratios of carbohydrate to total fiber, carbohydrate to cereal fiber, starch to total fiber, and starch to cereal fiber intakes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary Heart Disease (CHD)
Time Frame: June 1984 - June 2012
CHD includes both fatal and non-fatal myocardial infarction
June 1984 - June 2012

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard School of Public Health (HSPH)

Collaborators

National Cancer Institute (NCI)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Heart, Lung, and Blood Institute (NHLBI)
Kuwait Foundation for the Advancement of Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 1976

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

July 10, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 12, 2017

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Carb Quality and CHD NHS HPFS
  • UM1CA186107 (U.S. NIH Grant/Contract)
  • UM1CA167552 (U.S. NIH Grant/Contract)
  • HL34594 (Other Grant/Funding Number: NHLBI)
  • HL35464 (Other Grant/Funding Number: NHLBI)
  • DK58845 (Other Grant/Funding Number: NIDDK)
  • KFAS012016 (Other Grant/Funding Number: Kuwait Foundation for the Advancement of Science)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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