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Trial registered on ANZCTR

Registration number
Ethics application status
Submitted, not yet approved
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of Sulforaphane from Natural Broccoli Sprout Supplements in Pregnancy.
Scientific title
Pharmacokinetics of Sulforaphane from Natural Broccoli Sprout Supplements in Pregnancy: a prospective, open label trial.
Secondary ID [1] 292496 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This trial is linked with ANZCTR, ACTRN:12617000567325

Health condition
Health condition(s) or problem(s) studied:
Pre-eclampsia. 304130 0
Condition category
Condition code
Reproductive Health and Childbirth 303462 303462 0 0
Normal pregnancy
Reproductive Health and Childbirth 303463 303463 0 0
Fetal medicine and complications of pregnancy

Study type
Description of intervention(s) / exposure
All participants will be administered:
Supplement name: BroccoMax Broccoli Seed Extract (Myrosinase activated) . Delayed release. Manufacturer: Jarrow Formulas
Sulforaphane glucosinolate content 30mg per tablet (capsule)
1) Single dose (2 capsules)
2) The mode of administration: oral
Intervention code [1] 298676 0
Treatment: Other
Comparator / control treatment
The trial is the partner of our other ANZCTR study: ACTRN 12617000567325. The trial recruited n=6 non pregnant, healthy participants (3 male and 3 female). These 6 non-pregnant participants were given 2 different broccoli spout supplements in order to ascertain which one elevated serum sulforaphane levels the most. The results generated from the study, recruitment & data collection period: June 2017 to July 2017, have been used in the design of the study which will now be undertaken in pregnant women and will form a historical control group.
Control group

Primary outcome [1] 302835 0
The primary outcome of the trial is to ascertain the serum level of sulforaphane following the ingestion of a broccoli sprout supplement in healthy, pregnant women.

Timepoint [1] 302835 0
Blood samples will be collected from participants for pharmacokinetic (PK) analysis: before ingestion of the supplement (5 minutes, or less) and then following ingestion of the supplement, at a 'desired' eight further targeted time points of: 15 (+/-5) minutes, 30 (+/-5) minutes, 60 (+/-5) minutes, 90 (+/-5) minutes, 120 (+/-15) minutes, 240 (+/-15) minutes, 480 (+/-15) minutes and 720 (+/-15) minutes.
Secondary outcome [1] 337196 0
To compare the data with that obtained previously from a healthy, non pregnant population who were administered the same supplement (ANZCTR, ACTRN:12617000567325).
Timepoint [1] 337196 0
At the time of data analysis, once all the Ok sampling and laboratory analysis of blood samples has been completed.

Key inclusion criteria
Healthy, pregnant with a singleton fetus between 24 to 36 weeks gestation.

Able to read and understand the Patient Information and Consent Form, and to provide written, informed consent.
Minimum age
18 Years
Maximum age
55 Years
Can healthy volunteers participate?
Key exclusion criteria
Pregnant women who are taking a medication, or who have a medical or pregnancy related condition, that may have the potential to interfere with the pharmacokinetics of the broccoli sprout supplement.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not applicable
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The study is an exploratory study to obtain Pk data related to the ingestion of broccoli sprout supplements, the n=6 participants was chosen based on the data available from previous, similar studies.
Participant demographic data will be assessed for normality. Characteristics of the two groups will be tabulated and compared using the appropriate statistical test (e.g. Chi 2, independent t-test, Mann-Whitney test). Nonparametric data will be expressed as median and interquartile range (IQR). A p-value <0.05 (two-tailed) will be regarded as statistically signi cant. Data will be analysed using the SPSS statistical package (SPSS 24.0, IBM Corp, Armonk, New York, USA).
PK data will analysed by nonlinear mixed-effects modelling.

Recruitment status
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Prior to HREC approval, the project was developed further and has now been undertaken as a PhD project. ACTRN12618001655235.
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 8584 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 16692 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 297067 0
Name [1] 297067 0
Monash University
Address [1] 297067 0
Monash University, Department of Obstetrics and Gynaecology
Monash Medical Centre
246 Clayton Road
Victoria 3168
Country [1] 297067 0
Funding source category [2] 297071 0
Name [2] 297071 0
The Hudson Institute of Medical Research, The Ritchie Centre
Address [2] 297071 0
Hudson Institute of Medical Research
27-31 Wright Street
Victoria 3168
Country [2] 297071 0
Primary sponsor type
Monash Health
Monash Medical Centre
246 Clayton Road
Victoria 3168
Secondary sponsor category [1] 296074 0
Name [1] 296074 0
Address [1] 296074 0
Country [1] 296074 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298248 0
Monash Health, Human Research Ethics Committee
Ethics committee address [1] 298248 0
Monash Health Research Directorate
Monash Medical Centre
246 Clayton Road
Victoria 3168
Ethics committee country [1] 298248 0
Date submitted for ethics approval [1] 298248 0
Approval date [1] 298248 0
Ethics approval number [1] 298248 0

Brief summary
Sulforaphane is a naturally occurring compound belonging to the isothiocyanate group. It can be obtained naturally through cruciferous vegetables with broccoli sprouts being one of the richest sources. Sulforaphane obtained through ingested broccoli sprouts are activated by myrosinase, a chemical that is released by chewing of the vegetable. Myrosinase is also present in the gut flora of individuals and mediates the conversion of precursor compound to bioavailable sulforaphane. Previous studies in humans has demonstrated the antioxidative, anti-inflammatory effects of Sulforaphane and its ability to protect against endothelial dysfunction and end organ damage. Therefore, we believe sulforaphane may have a potential clinical utility in maternity care as a ‘low risk’ intervention for the treatment of pre-eclampsia.

The aim of the research project is to evaluate the pharmacokinetics (PK) of sulforaphane obtained through the ingestion of a natural broccoli sprout supplement in a cohort of healthy women 24-36 weeks pregnant with one baby, n=6

Participation involves the ingestion of two tablets (together) of the broccoli sprout supplement with associated PK blood sampling at nine pre-determined time points, one just prior to ingestion of the supplement and then following at: 15, 30, 60, 90, 120, 240, 480, 720 minute intervals.
Trial website
Not Applicable
Trial related presentations / publications
Public notes

Principal investigator
Name 76466 0
Prof Euan M. Wallace
Address 76466 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre
246 Clayton Road
Victoria 3168
Country 76466 0
Phone 76466 0
+61 3 9594 5145
Fax 76466 0
+61 3 9594 5003
Email 76466 0
Contact person for public queries
Name 76467 0
Ms Ms Yizhen Liu
Address 76467 0
The Ritchie Centre, Hudson Institute of Medical Research and Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre
246 Clayton Road
Victoria 3168
Country 76467 0
Phone 76467 0
+61 3 8572 2840
Fax 76467 0
+61 3 9594 6811
Email 76467 0
Contact person for scientific queries
Name 76468 0
Prof Euan M. Wallace
Address 76468 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre
246 Clayton Road
Victoria 3168
Country 76468 0
Phone 76468 0
+61 3 9594 5145
Fax 76468 0
+61 3 9594 5003
Email 76468 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
The trial has been withdrawn prior to HREC approval. Therefore, there will be no data to share, because the trial did not start.
What supporting documents are/will be available?
No other documents available
Summary results
No Results