- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01743924
Bioavailability of Chemopreventive and Nutritional Compounds in Broccoli
Bioavailability of Bioactive Compounds in Broccoli
Study Overview
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
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Murcia, Spain, 30003
- Hospital General Universitario Reina Sofía
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Raw
Broccoli,200 grams
|
To eat this plant material
Other Names:
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Experimental: cooked
Microwaved, 200 grams
|
To eat this plant material
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 4 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Maria Concepcion Maeztu Sardiña, Doctor, Comite Etico de Investigacion Clinica
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Broccoli_Bioav.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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