Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252018
Status:
COMPLETED
Last Update Posted:
2008-05-14
First Post:
2005-11-10
Brief Title:
The Effect of Broccoli Sprouts as a Nutritional Supplement in the Prevention of Cardiovascular Disease
Sponsor:
Bispebjerg Hospital
Organization:
Bispebjerg Hospital
Study Overview
Official Title:
The Effect of Broccoli Sprouts as a Nutritional Supplement in the Prevention of Cardiovascular Disease
Status:
COMPLETED
Status Verified Date:
2008-05
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 purpose of this study is to investigate whether a daily intake of dried broccoli sprouts will improve the endothelial function of the participants as measured by Flow mediated dilation FMD
The dried sprouts are chosen because broccoli sprouts are known as containing large amounts af the glucosinolate glucoraphanin which in vitro and in animal models has been shown to have a positive effect on the endothelium as measured by NO release
The dried sprouts are chosen because broccoli sprouts are known as containing large amounts af the glucosinolate glucoraphanin which in vitro and in animal models has been shown to have a positive effect on the endothelium as measured by NO release
Detailed Description:
Inflammation plays an important role in the development of atherosclerosis The initial site of damage is the endothelium and secondarily the rest of the vascular wall is involved Hypotheses concerning the development of these lesions have introduced the concept of oxidative stress an imbalance between oxidants and antioxidants in favor of the oxidants potentially leading to damage as having a key role in the development of atherosclerosis Consequently much interest has been focused on attenuating oxidative stress in order to minimize this damage
Clinical trials for the study of the effect of antioxidants on the atherosclerotic process using micronutrients with a reductive potential have failed to demonstrate a benefit for the patients and some have even shown an increased mortality
An alternative is to induce the endogenous antioxidative defense of the cell One possibility is to increase the expression of enzymes responsible for neutralizing oxidative substances a group of enzymes relevant for this path are the phase 2 enzymes for instance gluthation-s-transferaseGsT
Broccoli sprouts have a very high content of GlucoraphaninGP a substance which has the ability to increase the expression of GsT
Experiments involving stroke prone hypertensive rats and humans have indicated that GP in broccoli sprouts have a beneficial effect against oxidative stress In the experiment with the rats a consequence of the protection against oxidative stress was an increase in endothelial dependant vasodilationEDV This finding is important because low EDV predicts development of atherosclerosis
We find that induction of enzymes with antioxidant capabilities could be beneficial for people with atherosclerosis and that a study of the effects of broccoli sprouts on endothelial function in conditions with endothelial dysfunction are important as an intermediary step before clinical studies are performed
Hypothesis Broccoli sprouts containing high levels of GP induce phase 2 enzymes in the human endothelium thereby making the endothelium more resistant to inflammatory damage Attenuation of damage should increase nitric oxide NO bioavailability and thus improve EDV of patients being in risk of cardiovascular disease
Methods Broccoli sprouts will be harvested after 4 days to obtain the highest amount of GP per unit of dry weight After harvesting the sprouts will be dried in order to avoid degradation of the GP content As placebo sprouts where the GP content is degraded will be used
The participants will receive 10 g dried broccoli sprouts per day for a period of four weeks 10 g dried sprouts has a GP content equivalent to the content of 1 to 10 kg of fresh broccoli
Blinding of the participants as well as the investigators will be insured
Participants
120 patients in three subgroups and 40 healthy controls giving a total of four groups
The groups will be investigated individually having each a treatment and a placebo arm
Patients will be screened during which interview BP weight height and blood test will be performed After informed consent is obtained they will be randomized by draw of an envelope to either placebo or active ingredient At the beginning of the study and every other week during the study the patients will be examined by BP weight blood samples and assessment of EDV by use of flow mediated dilationFMD
FMD will be performed by measuring increase of diameter of the brachial artery above the elbow before and after interruption of circulation to the forearm for a period of 5 minutes by use of a tourniquet placed below the elbow Flow through the brachial artery will be recorded immediately after circulation is restored for 15 s Dilation will be expressed as a ratio relative to the diameter prior to interruption in percent Blood samples will be analyzed for GP content and metabolites at KVL
Statistics We have determined σ in our studies to be less than 25 which is comparable to results form other groups Assuming a σ of 3 and a minimal detectable difference of 3 usually the FMD is approximately 5 will give a power of 85 when the level of significance is 5 with our group size
Ethics WE find the participants will have no risks and only minor inconveniences when participating in our study
The study is approved by the Ethics committee of Copenhagen and Frederiksberg Municipalities no 01-25704
The study will be published in a peer reviewed biomedical journal
Clinical trials for the study of the effect of antioxidants on the atherosclerotic process using micronutrients with a reductive potential have failed to demonstrate a benefit for the patients and some have even shown an increased mortality
An alternative is to induce the endogenous antioxidative defense of the cell One possibility is to increase the expression of enzymes responsible for neutralizing oxidative substances a group of enzymes relevant for this path are the phase 2 enzymes for instance gluthation-s-transferaseGsT
Broccoli sprouts have a very high content of GlucoraphaninGP a substance which has the ability to increase the expression of GsT
Experiments involving stroke prone hypertensive rats and humans have indicated that GP in broccoli sprouts have a beneficial effect against oxidative stress In the experiment with the rats a consequence of the protection against oxidative stress was an increase in endothelial dependant vasodilationEDV This finding is important because low EDV predicts development of atherosclerosis
We find that induction of enzymes with antioxidant capabilities could be beneficial for people with atherosclerosis and that a study of the effects of broccoli sprouts on endothelial function in conditions with endothelial dysfunction are important as an intermediary step before clinical studies are performed
Hypothesis Broccoli sprouts containing high levels of GP induce phase 2 enzymes in the human endothelium thereby making the endothelium more resistant to inflammatory damage Attenuation of damage should increase nitric oxide NO bioavailability and thus improve EDV of patients being in risk of cardiovascular disease
Methods Broccoli sprouts will be harvested after 4 days to obtain the highest amount of GP per unit of dry weight After harvesting the sprouts will be dried in order to avoid degradation of the GP content As placebo sprouts where the GP content is degraded will be used
The participants will receive 10 g dried broccoli sprouts per day for a period of four weeks 10 g dried sprouts has a GP content equivalent to the content of 1 to 10 kg of fresh broccoli
Blinding of the participants as well as the investigators will be insured
Participants
120 patients in three subgroups and 40 healthy controls giving a total of four groups
The groups will be investigated individually having each a treatment and a placebo arm
Patients will be screened during which interview BP weight height and blood test will be performed After informed consent is obtained they will be randomized by draw of an envelope to either placebo or active ingredient At the beginning of the study and every other week during the study the patients will be examined by BP weight blood samples and assessment of EDV by use of flow mediated dilationFMD
FMD will be performed by measuring increase of diameter of the brachial artery above the elbow before and after interruption of circulation to the forearm for a period of 5 minutes by use of a tourniquet placed below the elbow Flow through the brachial artery will be recorded immediately after circulation is restored for 15 s Dilation will be expressed as a ratio relative to the diameter prior to interruption in percent Blood samples will be analyzed for GP content and metabolites at KVL
Statistics We have determined σ in our studies to be less than 25 which is comparable to results form other groups Assuming a σ of 3 and a minimal detectable difference of 3 usually the FMD is approximately 5 will give a power of 85 when the level of significance is 5 with our group size
Ethics WE find the participants will have no risks and only minor inconveniences when participating in our study
The study is approved by the Ethics committee of Copenhagen and Frederiksberg Municipalities no 01-25704
The study will be published in a peer reviewed biomedical journal
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