NCT01743924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

Same day

First QC Date

November 30, 2012

Last Update Submit

December 4, 2012

Conditions

Bioavailability

Keywords

Broccoli; Isothiocyanates; Pharmacokinetics; Sulforaphane; Myrosinase

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Raw

EXPERIMENTAL

Broccoli,200 grams

Other: raw broccoli

cooked

EXPERIMENTAL

Microwaved, 200 grams

Other: raw broccoli

Interventions

raw broccoliOTHER

To eat this plant material

Also known as: Bimi, Kailan hybrid
Rawcooked

Eligibility Criteria

Age22 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Reina Sofía

Murcia, Murcia, 30003, Spain

Location

Study Officials

  • Maria Concepcion Maeztu Sardiña, Doctor

    Comité ético de investigación clínica

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 30, 2012

First Posted

December 6, 2012

Study Start

July 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

ES(1)