Cardiovascular DiseasesNCT00005548
Green Tea Consumption and Coronary Heart Disease
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To examine the prospective association of green tea consumption to the incidence and mortality of coronary heart disease (CHD) using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1999to Mar 2001
- 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
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To examine the prospective association of green tea consumption to the incidence and mortality of coronary heart disease (CHD) using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients.
Read the detailed description
BACKGROUND:
Both in vivo and in vitro experiments have show that flavonoids, antioxidants which are rich in green tea, are potentially as beneficial as vitamin E, beta-carotene and vitamin C in reducing the risk of cardiovascular disease. Thus, the possible preventive effects of green tea on CHD have begun to raise research interests in green tea sufficiently to inquire about its beneficial effects formally in humans. However, few epidemiologic studies have been carried out to directly examine the effects of green tea on CHD. The Honolulu Heart Program (HHP) is a 30 year longitudinal study of CHD and stroke among 8,006 Japanese American men living on Oahu Hawaii. Until the end of 1992, 1,888 men from this cohort were defined as having incident CHD; this includes 396 deaths due to CHD. The baseline examination for the HHP was conducted during 1965-68. A comprehensive physical examination and 24 hour dietary recall interview were administered. Within the original cohort more than 75 percent men reported to have drunk green tea daily. The amount consumed per day varied considerably from low to high doses. The high prevalence of green tea consumption coupled with dose information (i.e low, moderate and high consumption) provides good opportunities to examine the relationships of green tea consumption and CHD.
DESIGN NARRATIVE:
The study uses the Honolulu Heart Program data to examine the prospective association of green tea consumption to the incidence and mortality of CHD using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients.
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, Coronary Disease, Heart Diseases
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startApr 1999
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Boji Huang, University of Toledo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005548
- Sponsor's protocol ID
- 5092
- Other IDs
- R03HL062577
- Status last verified
- Jan 2005
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Green Tea Consumption and Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT00005548
- Acronym / sponsor ID
- 5092
- Conditions
- Cardiovascular Diseases, Coronary Disease, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1999
- Study completion
- Mar 2001 (actual)
- First posted
- 26 May 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 examine the prospective association of green tea consumption to the incidence and mortality of coronary heart disease (CHD) using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients.
Detailed description
BACKGROUND:
Both in vivo and in vitro experiments have show that flavonoids, antioxidants which are rich in green tea, are potentially as beneficial as vitamin E, beta-carotene and vitamin C in reducing the risk of cardiovascular disease. Thus, the possible preventive effects of green tea on CHD have begun to raise research interests in green tea sufficiently to inquire about its beneficial effects formally in humans. However, few epidemiologic studies have been carried out to directly examine the effects of green tea on CHD. The Honolulu Heart Program (HHP) is a 30 year longitudinal study of CHD and stroke among 8,006 Japanese American men living on Oahu Hawaii. Until the end of 1992, 1,888 men from this cohort were defined as having incident CHD; this includes 396 deaths due to CHD. The baseline examination for the HHP was conducted during 1965-68. A comprehensive physical examination and 24 hour dietary recall interview were administered. Within the original cohort more than 75 percent men reported to have drunk green tea daily. The amount consumed per day varied considerably from low to high doses. The high prevalence of green tea consumption coupled with dose information (i.e low, moderate and high consumption) provides good opportunities to examine the relationships of green tea consumption and CHD.
DESIGN NARRATIVE:
The study uses the Honolulu Heart Program data to examine the prospective association of green tea consumption to the incidence and mortality of CHD using multivariate analysis while controlling for the potential confounding effects of cholesterol, triglycerides, glucose and dietary nutrients.
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
- Male only
- 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 13 May 2016.
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Boji Huang
University of Toledo
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, 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 13 May 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?
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 May 2016.