Bioavailability of Chemopreventive and Nutritional Compounds in Broccoli

Bioavailability Clinical Trial

Official title:

Bioavailability of Bioactive Compounds in Broccoli

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01743924
• Other study ID #: Broccoli_Bioav.
• Status: Completed
• Phase: Phase 0
• First received: November 30, 2012
• Last updated: December 4, 2012
• Start date: July 2011
• Est. completion date: July 2011

Study information

• Verified date: December 2012
• Source: Universidad Politécnica de Cartagena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 22 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Bioavailability

Intervention

Other:
• raw broccoli
To eat this plant material

Locations

Country	Name	City	State
Spain	Hospital General Universitario Reina Sofía	Murcia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Politécnica de Cartagena	Hospital Universitario Reina Sofia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic fate of ITC of the kailan-hybrid broccoli after human comsuption	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.	Up to 4 weeks	No