Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120107
Status:
COMPLETED
Last Update Posted:
2017-03-14
First Post:
2005-07-07
Brief Title:
Teas Effect on Atherosclerosis Pilot Study TEA Study
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Teas Effect on Atherosclerosis Pilot Study TEA Study
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The researchers propose a pilot study of the effect of long-term tea intake on atherosclerosis Thirty patients at high risk for cardiovascular disease will be recruited and randomized to a six-month period of consumption of 3 cups per day of either tea supplied as black tea solids readily dissolved in hot or cold liquid or water
At baseline and after 6 months atherosclerosis in the aorta will be assessed using magnetic resonance imaging The primary outcomes of this pilot study will be compliance with tea intake and 2 MRI examinations As secondary outcomes standard and novel cardiovascular risk markers including inflammatory prothrombotic fibrinolytic vascular and metabolic factors will be measured
If successful this pilot study will form the basis for a larger long-term randomized trial to determine the effect of tea consumption on progression of atherosclerosis
At baseline and after 6 months atherosclerosis in the aorta will be assessed using magnetic resonance imaging The primary outcomes of this pilot study will be compliance with tea intake and 2 MRI examinations As secondary outcomes standard and novel cardiovascular risk markers including inflammatory prothrombotic fibrinolytic vascular and metabolic factors will be measured
If successful this pilot study will form the basis for a larger long-term randomized trial to determine the effect of tea consumption on progression of atherosclerosis
Detailed Description:
Tea is widely thought to have health benefits particularly on cardiovascular disease CVD The investigators group recently found that intake of 2 or more cups of tea per day was associated with a 44 lower long-term mortality rate than abstention from tea among 1900 patients hospitalized with myocardial infarction Short-term trials support a benefit of tea on endothelial function but long-term randomized trials of tea intake on CVD and atherosclerosis are needed to test the effects of tea definitively
The researchers propose a proof-of-principle pilot study of the effect of long-term tea intake on atherosclerosis From a large hospital-based primary care practice 30 patients at high risk for CVD will be recruited and randomized to a six-month period of consumption of 3 cups per day of either tea supplied as black tea solids readily dissolved in hot or cold liquid or water The polyphenol content of these solids will be confirmed at baseline and a single batch of tea throughout the study will be used At baseline and after 6 months aortic atherosclerosis using magnetic resonance imaging an accurate and reproducible method for measurement of arterial plaque size will be assessed Adherence using urinary catechins the primary flavonoids in tea will be measured The primary outcomes will be compliance with tea intake and 2 MRI examinations As secondary outcomes standard and novel cardiovascular risk markers including inflammatory prothrombotic fibrinolytic and metabolic factors will be measured The researchers will also assess the effects of tea consumption on oxidizability of LDL and VLDL cholesterol using a novel affinity-column chromatography approach and on endothelial integrity as assessed by serum markers of endothelial function If successful this pilot study will form the basis for a larger long-term randomized trial to determine the effect of tea consumption on progression of atherosclerosis
The researchers propose a proof-of-principle pilot study of the effect of long-term tea intake on atherosclerosis From a large hospital-based primary care practice 30 patients at high risk for CVD will be recruited and randomized to a six-month period of consumption of 3 cups per day of either tea supplied as black tea solids readily dissolved in hot or cold liquid or water The polyphenol content of these solids will be confirmed at baseline and a single batch of tea throughout the study will be used At baseline and after 6 months aortic atherosclerosis using magnetic resonance imaging an accurate and reproducible method for measurement of arterial plaque size will be assessed Adherence using urinary catechins the primary flavonoids in tea will be measured The primary outcomes will be compliance with tea intake and 2 MRI examinations As secondary outcomes standard and novel cardiovascular risk markers including inflammatory prothrombotic fibrinolytic and metabolic factors will be measured The researchers will also assess the effects of tea consumption on oxidizability of LDL and VLDL cholesterol using a novel affinity-column chromatography approach and on endothelial integrity as assessed by serum markers of endothelial function If successful this pilot study will form the basis for a larger long-term randomized trial to determine the effect of tea consumption on progression of atherosclerosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21AT001899 | NIH | None | httpsreporternihgovquickSearchR21AT001899 |