Diabetes MellitusNCT00252018
The Effect of Broccoli Sprouts as a Nutritional Supplement in the Prevention of Cardiovascular Disease
A study testing Daily intake of broccoli sprouts in people with Diabetes Mellitus and Hypertension, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Hypercholesterolemia
- What is being tested?
- Daily intake of broccoli sprouts
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Mar 2007
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from hypertension, having a diastolic blood pressure of above 90 mm Hg or a systolic blood pressure of more than 140 mm Hg.
- Patients suffering from NIDDM, according to present criteria for diagnosis of NIDDM:
- People with dyslipidemia (combination of total cholesterol above 5, LDL cholesterol above 3 and HDL cholesterol below 1.1)
- Healthy controls suffering from none of the above conditions, but otherwise (age, sex, BMI and lifestyle) corresponding to the patient groups.
Who cannot join
- Patients under the age of 18 at inclusion in the study.
- Pregnant or breastfeeding women
- Women of childbearing age with no safe method of contraception
- Patients receiving vitamin K-antagonists (coumarine, marcoumar etc)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Broccoli Sprouts as a Nutritional Supplement in the Prevention of Cardiovascular Disease.
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.
Read the 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-transferase(GsT).
Broccoli sprouts have a very high content of Glucoraphanin(GP) 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 vasodilation(EDV). 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 dilation(FMD).
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 2.5 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 01-257/04).
The study will be published in a peer reviewed biomedical journal
- Being tested
- Daily intake of broccoli sprouts
- Keywords
- Nutritional supplement, Prevention, Endothelial function, Flow mediated dilation
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily intake of broccoli sproutsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of endothelial function as measured by FMD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startJan 2006
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Christian Torp-Pedersen, MD, Study chair, Bispebjerg Hospital Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252018
- Sponsor's protocol ID
- KF 01-257/04
- Status last verified
- May 2008
- First submitted
- 10 Nov 2005
- Last updated
- 14 May 2008
- Results posted
- No
Publications
Wu L, Noyan Ashraf MH, Facci M, Wang R, Paterson PG, Ferrie A, Juurlink BH. Dietary approach to attenuate oxidative stress, hypertension, and inflammation in the cardiovascular system. Proc Natl Acad Sci U S A. 2004 May 4;101(18):7094-9. doi: 10.1073/pnas.0402004101. Epub 2004 Apr 21.
PubMed 15103025Murashima M, Watanabe S, Zhuo XG, Uehara M, Kurashige A. Phase 1 study of multiple biomarkers for metabolism and oxidative stress after one-week intake of broccoli sprouts. Biofactors. 2004;22(1-4):271-5. doi: 10.1002/biof.5520220154.
PubMed 15630296Fahey JW, Zhang Y, Talalay P. Broccoli sprouts: an exceptionally rich source of inducers of enzymes that protect against chemical carcinogens. Proc Natl Acad Sci U S A. 1997 Sep 16;94(19):10367-72. doi: 10.1073/pnas.94.19.10367.
PubMed 9294217Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5. doi: 10.1016/0140-6736(92)93147-f.
PubMed 1359209Brunner H, Cockcroft JR, Deanfield J, Donald A, Ferrannini E, Halcox J, Kiowski W, Luscher TF, Mancia G, Natali A, Oliver JJ, Pessina AC, Rizzoni D, Rossi GP, Salvetti A, Spieker LE, Taddei S, Webb DJ; Working Group on Endothelins and Endothelial Factors of the European Society of Hypertension. Endothelial function and dysfunction. Part II: Association with cardiovascular risk factors and diseases. A statement by the Working Group on Endothelins and Endothelial Factors of the European Society of Hypertension. J Hypertens. 2005 Feb;23(2):233-46. doi: 10.1097/00004872-200502000-00001.
PubMed 15662207Matusheski NV, Juvik JA, Jeffery EH. Heating decreases epithiospecifier protein activity and increases sulforaphane formation in broccoli. Phytochemistry. 2004 May;65(9):1273-81. doi: 10.1016/j.phytochem.2004.04.013.
PubMed 15184012Stocker R, Keaney JF Jr. Role of oxidative modifications in atherosclerosis. Physiol Rev. 2004 Oct;84(4):1381-478. doi: 10.1152/physrev.00047.2003.
PubMed 15383655Christiansen B, Bellostas Muguerza N, Petersen AM, Kveiborg B, Madsen CR, Thomas H, Ihlemann N, Sorensen JC, Kober L, Sorensen H, Torp-Pedersen C, Dominguez H. Ingestion of broccoli sprouts does not improve endothelial function in humans with hypertension. PLoS One. 2010 Aug 27;5(8):e12461. doi: 10.1371/journal.pone.0012461.
PubMed 20805984
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Broccoli Sprouts as a Nutritional Supplement in the Prevention of Cardiovascular Disease.
- ClinicalTrials.gov ID
- NCT00252018
- Acronym / sponsor ID
- KF 01-257/04
- Keywords
- Nutritional supplement, Prevention, Endothelial function, Flow mediated dilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 11 Nov 2005 (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.
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.
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-transferase(GsT).
Broccoli sprouts have a very high content of Glucoraphanin(GP) 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 vasodilation(EDV). 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 dilation(FMD).
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 2.5 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 01-257/04).
The study will be published in a peer reviewed biomedical journal
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients suffering from hypertension, having a diastolic blood pressure of above 90 mm Hg or a systolic blood pressure of more than 140 mm Hg.
- Patients suffering from NIDDM, according to present criteria for diagnosis of NIDDM:
- People with dyslipidemia (combination of total cholesterol above 5, LDL cholesterol above 3 and HDL cholesterol below 1.1)
- Healthy controls suffering from none of the above conditions, but otherwise (age, sex, BMI and lifestyle) corresponding to the patient groups.
Key exclusion criteria (4 listed)
- Patients under the age of 18 at inclusion in the study.
- Pregnant or breastfeeding women
- Women of childbearing age with no safe method of contraception
- Patients receiving vitamin K-antagonists (coumarine, marcoumar etc)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily intake of broccoli sprouts | Behavioural | – |
Primary outcome
Improvement of endothelial function as measured by FMD
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 14 May 2008.
- Background: PubMed 15103025Wu L, Noyan Ashraf MH, Facci M, Wang R, Paterson PG, Ferrie A, Juurlink BH. Dietary approach to attenuate oxidative stress, hypertension, and inflammation in the cardiovascular system. Proc Natl Acad Sci U S A. 2004 May 4;101(18):7094-9. doi: 10.1073/pnas.0402004101. Epub 2004 Apr 21.
- Background: PubMed 15630296Murashima M, Watanabe S, Zhuo XG, Uehara M, Kurashige A. Phase 1 study of multiple biomarkers for metabolism and oxidative stress after one-week intake of broccoli sprouts. Biofactors. 2004;22(1-4):271-5. doi: 10.1002/biof.5520220154.
- Background: PubMed 9294217Fahey JW, Zhang Y, Talalay P. Broccoli sprouts: an exceptionally rich source of inducers of enzymes that protect against chemical carcinogens. Proc Natl Acad Sci U S A. 1997 Sep 16;94(19):10367-72. doi: 10.1073/pnas.94.19.10367.
- Background: PubMed 1359209Celermajer DS, Sorensen KE, Gooch VM, Spiegelhalter DJ, Miller OI, Sullivan ID, Lloyd JK, Deanfield JE. Non-invasive detection of endothelial dysfunction in children and adults at risk of atherosclerosis. Lancet. 1992 Nov 7;340(8828):1111-5. doi: 10.1016/0140-6736(92)93147-f.
- Background: PubMed 15662207Brunner H, Cockcroft JR, Deanfield J, Donald A, Ferrannini E, Halcox J, Kiowski W, Luscher TF, Mancia G, Natali A, Oliver JJ, Pessina AC, Rizzoni D, Rossi GP, Salvetti A, Spieker LE, Taddei S, Webb DJ; Working Group on Endothelins and Endothelial Factors of the European Society of Hypertension. Endothelial function and dysfunction. Part II: Association with cardiovascular risk factors and diseases. A statement by the Working Group on Endothelins and Endothelial Factors of the European Society of Hypertension. J Hypertens. 2005 Feb;23(2):233-46. doi: 10.1097/00004872-200502000-00001.
- Background: PubMed 15184012Matusheski NV, Juvik JA, Jeffery EH. Heating decreases epithiospecifier protein activity and increases sulforaphane formation in broccoli. Phytochemistry. 2004 May;65(9):1273-81. doi: 10.1016/j.phytochem.2004.04.013.
- Background: PubMed 15383655Stocker R, Keaney JF Jr. Role of oxidative modifications in atherosclerosis. Physiol Rev. 2004 Oct;84(4):1381-478. doi: 10.1152/physrev.00047.2003.
- Derived from this study: PubMed 20805984Christiansen B, Bellostas Muguerza N, Petersen AM, Kveiborg B, Madsen CR, Thomas H, Ihlemann N, Sorensen JC, Kober L, Sorensen H, Torp-Pedersen C, Dominguez H. Ingestion of broccoli sprouts does not improve endothelial function in humans with hypertension. PLoS One. 2010 Aug 27;5(8):e12461. doi: 10.1371/journal.pone.0012461.
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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.
Christian Torp-Pedersen, MD study chair
Bispebjerg Hospital Department of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily intake of broccoli sprouts in people with Diabetes Mellitus and Hypertension, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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 14 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Improvement of endothelial function as measured by FMD. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00252018, which also lists 8 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 14 May 2008.