Carb Quality and CHD in US Adults

An observational study of Coronary Heart Disease, 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.

Trial summary

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. Read more about this study

Who is it for?: Ages 30 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Coronary Heart Disease
What is being tested?: Carbohydrate quality
How many people: 117,885 participants
Where: No sites listed yet
Study dates: Jun 1976to Jun 2012
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 30 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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%.

Who may be able to join

Participants of these two cohorts

Who cannot join

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

About this study

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

Read the 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).

Conditions: Coronary Heart Disease
Being tested: Carbohydrate quality
Medical subject headings: Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Carbohydrate qualityOther
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.

Study groups in NCT03214861
Study group	Role	What they receive
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. Receives: Other: Carbohydrate quality
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. Receives: Other: Carbohydrate quality

What is being measured

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

Coronary Heart Disease (CHD)
CHD includes both fatal and non-fatal myocardial infarction
Measured: June 1984 - June 2012

Timeline

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

Jun 1976Jun 2012

First posted12 Jul 2017
Study startJun 1976
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (44)Papers the sponsor has linked to this study.
Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
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
Observational model: Cohort
Time perspective: Prospective
Enrolment: 117,885 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03214861
Sponsor's protocol ID: Carb Quality and CHD NHS HPFS
Other IDs: UM1CA186107, UM1CA167552, HL34594, HL35464, DK58845, KFAS012016
Status last verified: Jul 2017
First submitted: 10 Jul 2017
Last updated: 13 Oct 2017
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.
PubMed 25520374
Huffman MD, Capewell S, Ning H, Shay CM, Ford ES, Lloyd-Jones DM. Cardiovascular health behavior and health factor changes (1988-2008) and projections to 2020: results from the National Health and Nutrition Examination Surveys. Circulation. 2012 May 29;125(21):2595-602. doi: 10.1161/CIRCULATIONAHA.111.070722. Epub 2012 Apr 30.
PubMed 22547667
Yang L, Colditz GA. Prevalence of Overweight and Obesity in the United States, 2007-2012. JAMA Intern Med. 2015 Aug;175(8):1412-3. doi: 10.1001/jamainternmed.2015.2405. No abstract available.
PubMed 26098405
Long-Term Trends in Diagnosed Diabetes. CDC's Division of Diabetes Translation. National Diabetes Surveillance System. October 2011. http://www.cdc.gov/diabetes/statistics
Mozumdar A, Liguori G. Persistent increase of prevalence of metabolic syndrome among U.S. adults: NHANES III to NHANES 1999-2006. Diabetes Care. 2011 Jan;34(1):216-9. doi: 10.2337/dc10-0879. Epub 2010 Oct 1.
PubMed 20889854
Stampfer MJ, Hu FB, Manson JE, Rimm EB, Willett WC. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med. 2000 Jul 6;343(1):16-22. doi: 10.1056/NEJM200007063430103.
PubMed 10882764
Akesson A, Larsson SC, Discacciati A, Wolk A. Low-risk diet and lifestyle habits in the primary prevention of myocardial infarction in men: a population-based prospective cohort study. J Am Coll Cardiol. 2014 Sep 30;64(13):1299-306. doi: 10.1016/j.jacc.2014.06.1190.
PubMed 25257629
U.S. Department of Agriculture and the U.S. Department of Health and Human Services. Nutrition and your health. Dietary guidelines for Americans. 1980.
McGuire S. U.S. Department of Agriculture and U.S. Department of Health and Human Services, Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, January 2011. Adv Nutr. 2011 May;2(3):293-4. doi: 10.3945/an.111.000430. Epub 2011 Apr 30. No abstract available.
PubMed 22332062
Siri-Tarino PW, Sun Q, Hu FB, Krauss RM. Meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease. Am J Clin Nutr. 2010 Mar;91(3):535-46. doi: 10.3945/ajcn.2009.27725. Epub 2010 Jan 13.
PubMed 20071648
Li Y, Hruby A, Bernstein AM, Ley SH, Wang DD, Chiuve SE, Sampson L, Rexrode KM, Rimm EB, Willett WC, Hu FB. Saturated Fats Compared With Unsaturated Fats and Sources of Carbohydrates in Relation to Risk of Coronary Heart Disease: A Prospective Cohort Study. J Am Coll Cardiol. 2015 Oct 6;66(14):1538-1548. doi: 10.1016/j.jacc.2015.07.055.
PubMed 26429077
Yu D, Shu XO, Li H, Xiang YB, Yang G, Gao YT, Zheng W, Zhang X. Dietary carbohydrates, refined grains, glycemic load, and risk of coronary heart disease in Chinese adults. Am J Epidemiol. 2013 Nov 15;178(10):1542-9. doi: 10.1093/aje/kwt178. Epub 2013 Sep 5.
PubMed 24008907
Rebello SA, Koh H, Chen C, Naidoo N, Odegaard AO, Koh WP, Butler LM, Yuan JM, van Dam RM. Amount, type, and sources of carbohydrates in relation to ischemic heart disease mortality in a Chinese population: a prospective cohort study. Am J Clin Nutr. 2014 Jul;100(1):53-64. doi: 10.3945/ajcn.113.076273. Epub 2014 Apr 30.
PubMed 24787492
Liu S, Willett WC, Stampfer MJ, Hu FB, Franz M, Sampson L, Hennekens CH, Manson JE. A prospective study of dietary glycemic load, carbohydrate intake, and risk of coronary heart disease in US women. Am J Clin Nutr. 2000 Jun;71(6):1455-61. doi: 10.1093/ajcn/71.6.1455.
PubMed 10837285
Yang Q, Zhang Z, Gregg EW, Flanders WD, Merritt R, Hu FB. Added sugar intake and cardiovascular diseases mortality among US adults. JAMA Intern Med. 2014 Apr;174(4):516-24. doi: 10.1001/jamainternmed.2013.13563.
PubMed 24493081

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Active, not recruitingPhase 4
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Coronary Artery Disease
Active, not recruiting
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Atrial Arrhythmia, Atrial Fibrillation
Recruiting
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All Coronary Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Carbohydrate Quality and Quantity and Risk of Coronary Heart Disease Among US Women and Men.
ClinicalTrials.gov ID: NCT03214861
Acronym / sponsor ID: Carb Quality and CHD NHS HPFS
Conditions: Coronary Heart Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 117,885 participants (actual)
Lead sponsor: Harvard School of Public Health (HSPH)University, hospital or other
Collaborators: Kuwait Foundation for the Advancement of Sciences, National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Jun 1976 (actual)
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 12 Jul 2017 (actual)
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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Nurses Health Study	–	Other: Carbohydrate qualityThe 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.
Health Professionals Follow-Up Study	–	Other: Carbohydrate qualityThe Health Professionals Follow-up Study (HPFS) was initiated in 1986 and recruited 51,529 US men between the ages of 40-75.

Who may qualify

Ages: 30 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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%.

Key inclusion criteria (1 listed)

Participants of these two cohorts

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Carbohydrate qualityThis 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.	Other	Health Professionals Follow-Up Study, Nurses Health Study

Primary outcome

Coronary Heart Disease (CHD)
Time frame: June 1984 - June 2012
CHD includes both fatal and non-fatal myocardial infarction

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 Oct 2017.
Background: PubMed 25520374Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2015 update: a report from the American Heart Association. Circulation. 2015 Jan 27;131(4):e29-322. doi: 10.1161/CIR.0000000000000152. Epub 2014 Dec 17. No abstract available.
Background: PubMed 22547667Huffman MD, Capewell S, Ning H, Shay CM, Ford ES, Lloyd-Jones DM. Cardiovascular health behavior and health factor changes (1988-2008) and projections to 2020: results from the National Health and Nutrition Examination Surveys. Circulation. 2012 May 29;125(21):2595-602. doi: 10.1161/CIRCULATIONAHA.111.070722. Epub 2012 Apr 30.
Background: PubMed 26098405Yang L, Colditz GA. Prevalence of Overweight and Obesity in the United States, 2007-2012. JAMA Intern Med. 2015 Aug;175(8):1412-3. doi: 10.1001/jamainternmed.2015.2405. No abstract available.
BackgroundLong-Term Trends in Diagnosed Diabetes. CDC's Division of Diabetes Translation. National Diabetes Surveillance System. October 2011. http://www.cdc.gov/diabetes/statistics
Background: PubMed 20889854Mozumdar A, Liguori G. Persistent increase of prevalence of metabolic syndrome among U.S. adults: NHANES III to NHANES 1999-2006. Diabetes Care. 2011 Jan;34(1):216-9. doi: 10.2337/dc10-0879. Epub 2010 Oct 1.
Background: PubMed 10882764Stampfer MJ, Hu FB, Manson JE, Rimm EB, Willett WC. Primary prevention of coronary heart disease in women through diet and lifestyle. N Engl J Med. 2000 Jul 6;343(1):16-22. doi: 10.1056/NEJM200007063430103.
Background: PubMed 25257629Akesson A, Larsson SC, Discacciati A, Wolk A. Low-risk diet and lifestyle habits in the primary prevention of myocardial infarction in men: a population-based prospective cohort study. J Am Coll Cardiol. 2014 Sep 30;64(13):1299-306. doi: 10.1016/j.jacc.2014.06.1190.
BackgroundU.S. Department of Agriculture and the U.S. Department of Health and Human Services. Nutrition and your health. Dietary guidelines for Americans. 1980.
Background: PubMed 22332062McGuire S. U.S. Department of Agriculture and U.S. Department of Health and Human Services, Dietary Guidelines for Americans, 2010. 7th Edition, Washington, DC: U.S. Government Printing Office, January 2011. Adv Nutr. 2011 May;2(3):293-4. doi: 10.3945/an.111.000430. Epub 2011 Apr 30. No abstract available.
Background: PubMed 20071648Siri-Tarino PW, Sun Q, Hu FB, Krauss RM. Meta-analysis of prospective cohort studies evaluating the association of saturated fat with cardiovascular disease. Am J Clin Nutr. 2010 Mar;91(3):535-46. doi: 10.3945/ajcn.2009.27725. Epub 2010 Jan 13.
Background: PubMed 26429077Li Y, Hruby A, Bernstein AM, Ley SH, Wang DD, Chiuve SE, Sampson L, Rexrode KM, Rimm EB, Willett WC, Hu FB. Saturated Fats Compared With Unsaturated Fats and Sources of Carbohydrates in Relation to Risk of Coronary Heart Disease: A Prospective Cohort Study. J Am Coll Cardiol. 2015 Oct 6;66(14):1538-1548. doi: 10.1016/j.jacc.2015.07.055.
Background: PubMed 24008907Yu D, Shu XO, Li H, Xiang YB, Yang G, Gao YT, Zheng W, Zhang X. Dietary carbohydrates, refined grains, glycemic load, and risk of coronary heart disease in Chinese adults. Am J Epidemiol. 2013 Nov 15;178(10):1542-9. doi: 10.1093/aje/kwt178. Epub 2013 Sep 5.
Individual participant dataSharing planned: No

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Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Heart Disease, run by Harvard School of Public Health (HSPH).

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

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. 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 Oct 2017. 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?

Coronary Heart Disease (CHD) (time frame: June 1984 - June 2012). 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 NCT03214861, which also lists 44 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 Oct 2017.