The Effect of Broccoli Sprouts as a Nutritional Supplement in the Prevention of Cardiovascular Disease

NCT00252018 | Completed

• 1 other identifier: KF 01-257/04
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Hypertension; Hypercholesterolemia; Cardiovascular Disease

Keywords

Nutritional supplement; Prevention; Endothelial function; Flow mediated dilation

Outcome Measures

Primary Outcomes (1)

• Improvement of endothelial function as measured by FMD

Interventions

Daily intake of broccoli sprouts BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or breastfeeding women
• Women of childbearing age with no safe method of contraception
• Patients receiving vitamin K-antagonists (coumarine, marcoumar etc)

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Related Publications (8)

• 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.

  PMID: 15103025 BACKGROUND

• 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. doi: 10.1002/biof.5520220154.

  PMID: 15630296 BACKGROUND

• 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. doi: 10.1073/pnas.94.19.10367.

  PMID: 9294217 BACKGROUND

• 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. doi: 10.1016/0140-6736(92)93147-f.

  PMID: 1359209 BACKGROUND

• 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. doi: 10.1097/00004872-200502000-00001.

  PMID: 15662207 BACKGROUND

• Matusheski 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.

  PMID: 15184012 BACKGROUND

• Stocker R, Keaney JF Jr. Role of oxidative modifications in atherosclerosis. Physiol Rev. 2004 Oct;84(4):1381-478. doi: 10.1152/physrev.00047.2003.

  PMID: 15383655 BACKGROUND

• Christiansen 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.

  PMID: 20805984 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hypercholesterolemia; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Christian Torp-Pedersen, MD

  Bispebjerg Hospital Department of Cardiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 11, 2005
• Study Start: January 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: May 14, 2008

Record last verified: 2008-05

Locations

DK (1)