ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioavailability of Chemopreventive and Nutritional Compounds in Broccoli

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Bioavailability Other: raw broccoli Early Phase 1

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 : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Bioavailability of Bioactive Compounds in Broccoli
Study Start Date : July 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: Raw
Broccoli,200 grams
Other: raw broccoli
To eat this plant material
Other Names:
  • Bimi
  • Kailan hybrid
Experimental: cooked
Microwaved, 200 grams
Other: raw broccoli
To eat this plant material
Other Names:
  • Bimi
  • Kailan hybrid



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01743924


Locations
Spain
Hospital General Universitario Reina Sofía
Murcia, Spain, 30003
Sponsors and Collaborators
Universidad Politécnica de Cartagena
Hospital Universitario Reina Sofia de Cordoba
Investigators
Study Chair: Maria Concepcion Maeztu Sardiña, Doctor Comité ético de investigación clínica

Responsible Party: Ginés Benito Martínez Hernández, Doctor, Universidad Politécnica de Cartagena
ClinicalTrials.gov Identifier: NCT01743924     History of Changes
Other Study ID Numbers: Broccoli_Bioav.
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Keywords provided by Ginés Benito Martínez Hernández, Universidad Politécnica de Cartagena:
Broccoli; Isothiocyanates; Pharmacokinetics; Sulforaphane; Myrosinase