Ignite Creation Date:
2024-05-06 @ 1:55 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01935362
Status:
COMPLETED
Last Update Posted:
2014-04-01
First Post:
2013-08-20
Brief Title:
Impact of Oranges on Cardiovascular Health
Sponsor:
University of Leeds
Organization:
University of Leeds
Study Overview
Official Title:
Bioavailability of Flavanones Compounds and Their Impact on Cardiovascular Health
Status:
COMPLETED
Status Verified Date:
2014-03
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:
Cardiovascular disease CVD is the leading cause of deaths in the Western world Established risk factors include high LDL cholesterol high blood pressure and diabetes Poor blood vessel health is considered a predictor of future CVD risk but can be reversed Several different measurements can be used to determine blood vessel health such as blood pressure BP and newer techniques which measure blood flow through the arteries after a blood pressure cuff restricts blood flow for a few minutes in one arm
Flavonoids are compounds found in plant-based foods and are associated with a reduced risk of CVD From the previous studies there is strong evidence that orange juice and citrus foods which have higher amount of specific citrus flavonoids improved cardiovascular risk factors such as BP and blood vessel health Absorption of citrus flavonoids occurs in the colon after bacteria breakdown the forms found in food After the flavonoids are absorbed into the blood they are modification by liver enzymes before they are excreted in the urine A large range of citrus flavonoid have been found excreted in the urinary ranging anywhere from 0-57 of the dose Variation in the potential health effect may reflect the level of the citrus flavonoid absorbed and this is not often considered in human studies
This study is a 4-week double-blinded randomized cross-over intervention trial using a commercially-available orange juice supplement and a placebo control The aims of the study are to determine whether orange juice supplements reduce blood pressure and improve blood vessel health after 4 weeks Furthermore to determine if there is a relationship between absorption of flavonoids as measured by urinary excretion and changes in blood pressure or blood vessel health
The participants will need to attend 4 sessions on 4 separate study days every 4 weeks for 12 weeks On each study day they will have their weight height waist circumference and blood pressure measured A finger-prick blood sample using a single-use lancet Accu-Chek Safe T Pro Plus will be taken to check the fasting blood glucose level Blood flow in fingertips will be monitored before and after reducing blood flow in your forearm using a blood pressure cuff called an EndoPAT Participants will be asked to collect urine for 24 hr on each of the study days and to consume the supplements provided daily for two sets of 4 weeks there will be 4 weeks in the middle without any supplements
An improvement in blood pressure andor blood flow will provide evidence that blood vessel health has improved through short-term 4 week use of a citrus flavonoid supplement
Flavonoids are compounds found in plant-based foods and are associated with a reduced risk of CVD From the previous studies there is strong evidence that orange juice and citrus foods which have higher amount of specific citrus flavonoids improved cardiovascular risk factors such as BP and blood vessel health Absorption of citrus flavonoids occurs in the colon after bacteria breakdown the forms found in food After the flavonoids are absorbed into the blood they are modification by liver enzymes before they are excreted in the urine A large range of citrus flavonoid have been found excreted in the urinary ranging anywhere from 0-57 of the dose Variation in the potential health effect may reflect the level of the citrus flavonoid absorbed and this is not often considered in human studies
This study is a 4-week double-blinded randomized cross-over intervention trial using a commercially-available orange juice supplement and a placebo control The aims of the study are to determine whether orange juice supplements reduce blood pressure and improve blood vessel health after 4 weeks Furthermore to determine if there is a relationship between absorption of flavonoids as measured by urinary excretion and changes in blood pressure or blood vessel health
The participants will need to attend 4 sessions on 4 separate study days every 4 weeks for 12 weeks On each study day they will have their weight height waist circumference and blood pressure measured A finger-prick blood sample using a single-use lancet Accu-Chek Safe T Pro Plus will be taken to check the fasting blood glucose level Blood flow in fingertips will be monitored before and after reducing blood flow in your forearm using a blood pressure cuff called an EndoPAT Participants will be asked to collect urine for 24 hr on each of the study days and to consume the supplements provided daily for two sets of 4 weeks there will be 4 weeks in the middle without any supplements
An improvement in blood pressure andor blood flow will provide evidence that blood vessel health has improved through short-term 4 week use of a citrus flavonoid supplement
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None