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Completed

NCT Number: NCT03214861

Carb Quality and CHD in US Adults

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.

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Key information

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate quality

Other

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.

Primary outcomes

  1. Coronary Heart Disease (CHD)

    Time frame: June 1984 - June 2012

    CHD includes both fatal and non-fatal myocardial infarction

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
1976
Primary completion
2012
Study completion
2012
First posted
Jul 12, 2017
Registry last updated
Oct 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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