Cardiovascular DiseasesNCT00006504
Flavonoids and Cardiovascular Disease
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the association between flavonoids intake and the prevention of incident cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Aug 2000to Jul 2002
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine the association between flavonoids intake and the prevention of incident cardiovascular disease (CVD).
Read the detailed description
BACKGROUND:
Basic science, clinical observation, and epidemiologic studies have all contributed to an emerging body of evidence on the potential role of flavonoids, a group of polyphenolic compounds with antioxidant properties, in the prevention of cardiovascular disease. However, the few existing studies on flavonoids or its food sources have provided inconsistent results, usually focusing on the primary prevention of coronary heart disease mortality. The study used the small grant mechanism (R03) to analyze previously collected data.
DESIGN NARRATIVE:
The investigators examined whether flavonoid intake was associated with the risk of incident CVD, and whether specific food sources of flavonoids--including tea, onions, apples, red wine, and other foods--were associated with the risk of incident CVD. The investigators processed and analyzed previously collected data of 39,876 middle-aged and older women free of CVD; the Women's Antioxidant Cardiovascular Study (WACS), a prospective study of 8,171 middle-aged and older women with pre-existing CVD or more than three coronary risk factors; the Normative Aging Study (NAS), a prospective study of 2,280 middle-aged and older men; and the Boston Area Health Study (BAHS), a case-control study of first nonfatal myocardial infarction in men and women aged less than 76 years. Using data from semiquantitative food frequency questionnaires administered in each study, the investigators determined individual intake of flavonoids and its food sources. Unlike previous studies, they examined flavonoids in relation to both the primary and secondary prevention of incident cardiovascular disease (CVD), consisting of confirmed cases of nonfatal myocardial infarction (Ml), nonfatal stroke, revascularization procedures, and CVD death.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Myocardial Infarction, Coronary Disease
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Stroke, Myocardial Infarction, Coronary Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2000 (estimated)
- Study startAug 2000
- Study completionJul 2002
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
- Howard Sesso, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006504
- Sponsor's protocol ID
- 945
- Other IDs
- R03HL065727
- Status last verified
- Aug 2004
- First submitted
- 16 Nov 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Sesso HD, Liu S, Gaziano JM, Buring JE. Dietary lycopene, tomato-based food products and cardiovascular disease in women. J Nutr. 2003 Jul;133(7):2336-41. doi: 10.1093/jn/133.7.2336.
PubMed 12840203Sesso HD, Gaziano JM, Liu S, Buring JE. Flavonoid intake and the risk of cardiovascular disease in women. Am J Clin Nutr. 2003 Jun;77(6):1400-8. doi: 10.1093/ajcn/77.6.1400.
PubMed 12791616
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flavonoids and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00006504
- Acronym / sponsor ID
- 945
- Conditions
- Cardiovascular Diseases, Heart Diseases, Cerebrovascular Accident, Myocardial Infarction, Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Aug 2000
- Study completion
- Jul 2002 (actual)
- First posted
- 17 Nov 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 determine the association between flavonoids intake and the prevention of incident cardiovascular disease (CVD).
Detailed description
BACKGROUND:
Basic science, clinical observation, and epidemiologic studies have all contributed to an emerging body of evidence on the potential role of flavonoids, a group of polyphenolic compounds with antioxidant properties, in the prevention of cardiovascular disease. However, the few existing studies on flavonoids or its food sources have provided inconsistent results, usually focusing on the primary prevention of coronary heart disease mortality. The study used the small grant mechanism (R03) to analyze previously collected data.
DESIGN NARRATIVE:
The investigators examined whether flavonoid intake was associated with the risk of incident CVD, and whether specific food sources of flavonoids--including tea, onions, apples, red wine, and other foods--were associated with the risk of incident CVD. The investigators processed and analyzed previously collected data of 39,876 middle-aged and older women free of CVD; the Women's Antioxidant Cardiovascular Study (WACS), a prospective study of 8,171 middle-aged and older women with pre-existing CVD or more than three coronary risk factors; the Normative Aging Study (NAS), a prospective study of 2,280 middle-aged and older men; and the Boston Area Health Study (BAHS), a case-control study of first nonfatal myocardial infarction in men and women aged less than 76 years. Using data from semiquantitative food frequency questionnaires administered in each study, the investigators determined individual intake of flavonoids and its food sources. Unlike previous studies, they examined flavonoids in relation to both the primary and secondary prevention of incident cardiovascular disease (CVD), consisting of confirmed cases of nonfatal myocardial infarction (Ml), nonfatal stroke, revascularization procedures, and CVD death.
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
- All
- 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 16 Mar 2016.
- Background: PubMed 12840203Sesso HD, Liu S, Gaziano JM, Buring JE. Dietary lycopene, tomato-based food products and cardiovascular disease in women. J Nutr. 2003 Jul;133(7):2336-41. doi: 10.1093/jn/133.7.2336.
- Background: PubMed 12791616Sesso HD, Gaziano JM, Liu S, Buring JE. Flavonoid intake and the risk of cardiovascular disease in women. Am J Clin Nutr. 2003 Jun;77(6):1400-8. doi: 10.1093/ajcn/77.6.1400.
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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.
Howard Sesso
Brigham and Women's Hospital
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 16 Mar 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 NCT00006504, 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 16 Mar 2016; AzTrials last refreshed its copy on 30 Oct 2026.