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Bioavailability of Chemopreventive and Nutritional Compounds in Broccoli

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ClinicalTrials.gov Identifier: NCT01743924
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Collaborator:
Hospital Universitario Reina Sofia de Cordoba
Information provided by (Responsible Party):
Ginés Benito Martínez Hernández, Universidad Politécnica de Cartagena

Tracking Information
First Submitted Date  ICMJE November 30, 2012
First Posted Date  ICMJE December 6, 2012
Last Update Posted Date December 6, 2012
Study Start Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2012)
Metabolic fate of ITC of the kailan-hybrid broccoli after human comsuption [ Time Frame: Up to 4 weeks ]
Glucosinolates (sulphur-containing compounds) are hydrolyzed by the plant enzyme myrosinase to isothiocyanates (ITC), which have chemopreventive properties. Previous studies have shown that cooking process of vegetables may vary the human absorption of the correspondent nutritional and bioactive compounds.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability of Chemopreventive and Nutritional Compounds in Broccoli
Official Title  ICMJE Bioavailability of Bioactive Compounds in Broccoli
Brief Summary The aim of this study was to determine the absorption of isothiocyanates (ITC) after ingestion of kailan-hybrid broccoli through the analysis of the correspondent urinary biomarkers. Furthermore, the effect of cooking (microwave) on the mentioned metabolic fate of these ITC was studied comparing to the uncooked vegetable.
Detailed Description

Background Glucosinolates (sulphur-containing compounds) are hydrolyzed by the plant enzyme myrosinase to ITC, which have chemopreventive properties. No information has been reported about the metabolic fate of ITC in the kailan-hybrid broccoli, which physicochemical characteristics could greatly influence that metabolic fate. Previous studies have shown that cooking process of vegetables may vary the human absorption of the correspondent nutritional and bioactive compounds.

Research Methods & Procedures A cross-over-design study of 7 subjects after ingestion of 200-g raw or microwaved kailan-hybrid broccoli was conducted. Total ITC equivalents in the vegetable, urine and blood samples were determined by HPLC as the cyclocondensation product of 1,2-benzenedithiol.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Bioavailability
Intervention  ICMJE Other: raw broccoli
To eat this plant material
Other Names:
  • Bimi
  • Kailan hybrid
Study Arms  ICMJE
  • Experimental: Raw
    Broccoli,200 grams
    Intervention: Other: raw broccoli
  • Experimental: cooked
    Microwaved, 200 grams
    Intervention: Other: raw broccoli
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2012)
7
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with a body mass index between 19 and 28.
  • Subjects age: 22-50 years-old.
  • Good health of subjects: confirmed by medical history, physical examination and clinical laboratory analysis of urine and blood (complete blood count and liver function markers including serum glutamic-pyruvic transaminase bilirubin test and glucose-6-phosphate dehydrogenase).

Exclusion Criteria:

  • Tobacco smoking.
  • Use of regular medications.
  • Had taken antibiotics for 4 weeks immediately preceding the study.
  • History of kidney stones, diabetes mellitus, bleeding disorders or family history of iron overload/hemochromatosis.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01743924
Other Study ID Numbers  ICMJE Broccoli_Bioav.
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ginés Benito Martínez Hernández, Universidad Politécnica de Cartagena
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Universidad Politécnica de Cartagena
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Hospital Universitario Reina Sofia de Cordoba
Investigators  ICMJE
Study Chair: Maria Concepcion Maeztu Sardiña, Doctor Comité ético de investigación clínica
PRS Account Universidad Politécnica de Cartagena
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP