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

This study has been completed.
Sponsor:
Information provided by:
Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT00252018
First received: November 10, 2005
Last updated: May 13, 2008
Last verified: May 2008
  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:


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)
  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 31, 2014