The Effect of Broccoli Sprouts as a Nutritional Supplement in the Prevention of Cardiovascular Disease - Full Text View

Purpose

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.

Condition	Intervention
Diabetes Mellitus Hypertension Hypercholesterolemia Cardiovascular Disease	Behavioral: Daily intake of broccoli sprouts

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	The Effect of Broccoli Sprouts as a Nutritional Supplement in the Prevention of Cardiovascular Disease.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Diabetes Dietary Supplements High Blood Pressure

U.S. FDA Resources

Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:

Improvement of endothelial function as measured by FMD

Estimated Enrollment:	160
Study Start Date:	January 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00252018

Locations

Denmark
Bispebjerg Hospital
Copenhagen, Denmark, 2400

Sponsors and Collaborators

Bispebjerg Hospital

Investigators

Study Chair:

Christian Torp-Pedersen, MD

Bispebjerg Hospital Department of Cardiology

More Information

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. Epub 2004 Apr 21.

Murashima 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.

Fahey 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.

Celermajer 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.

Brunner 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. Review.

Matusheski NV, Juvik JA, Jeffery EH. Heating decreases epithiospecifier protein activity and increases sulforaphane formation in broccoli. Phytochemistry. 2004 May;65(9):1273-81.

Stocker R, Keaney JF Jr. Role of oxidative modifications in atherosclerosis. Physiol Rev. 2004 Oct;84(4):1381-478. Review.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Christiansen B, Bellostas Muguerza N, Petersen AM, Kveiborg B, Madsen CR, Thomas H, Ihlemann N, Sørensen JC, Køber L, Sørensen H, Torp-Pedersen C, Domínguez H. Ingestion of broccoli sprouts does not improve endothelial function in humans with hypertension. PLoS One. 2010 Aug 27;5(8):e12461.

ClinicalTrials.gov Identifier:	NCT00252018 History of Changes
Other Study ID Numbers:	KF 01-257/04
Study First Received:	November 10, 2005
Last Updated:	May 13, 2008
Health Authority:	Denmark: National Board of Health

Keywords provided by Bispebjerg Hospital:

Nutritional supplement
Prevention
Endothelial function
Flow mediated dilation

Additional relevant MeSH terms:

Cardiovascular Diseases
Diabetes Mellitus
Hypercholesterolemia
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013