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Trial registered on ANZCTR


Registration number
ACTRN12623000592640
Ethics application status
Approved
Date submitted
6/04/2023
Date registered
31/05/2023
Date last updated
25/06/2024
Date data sharing statement initially provided
31/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of broccoli sprout extracts in non-pregnant and pregnant women
Scientific title
Comparing broccoli sprout supplement formulations for circulating sulforaphane concentration in non-pregnant and pregnant women
Secondary ID [1] 309379 0
Nil
Universal Trial Number (UTN)
U1111-1290-8991
Trial acronym
Linked study record
This study is paired with ACTRN12623000591651, which investigated the maternal-fetal transfer of a broccoli sprout supplement. This current study is looking at the pharmacokinetic curve in non-pregnant and pregnant participants, whereas the linked study is looking at placental transfer and breast milk transfer of sulforaphane and metabolites after consuming a broccoli sprout extract.

Health condition
Health condition(s) or problem(s) studied:
Preeclampsia
 329632 0
Condition category
Condition code
Reproductive Health and Childbirth 326556 326556 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three different commercially available broccoli sprout extracts will be compared for their circulating concentration of sulforaphane. Participants will be enrolled into groups sequentially until allocation exhausted. Participants will be allocated to group 1 first, group 2 second and group 3 third.

Each participant provided a single dose from one of the three different extracts

Group 1 - two capsules (total dose - 500mg) stabilized sulforaphane formulation BROQ - total sulforaphane dose 26.1mg

Group 2 - two capsules (1400mg) broccoli sprout supplement GeneActiv Formulation E by Cell-Logic - total sulforaphane dose 21mg

Group 3 - four capsules (1760g) broccoli sprout supplement AVMACOL® Regular Strength
- total sulforaphane dose 21.8mg
Intervention code [1] 325835 0
Treatment: Drugs
Comparator / control treatment
Comparator - two capsules (1400mg) broccoli sprout supplement GeneActiv Formulation E by Cell-Logic - total sulforaphane dose 21mg
Control group
Active

Outcomes
Primary outcome [1] 334396 0
Circulating concentration of sulforaphane and metabolites with blood sample analysis

Timepoint [1] 334396 0
Time points post-dose
- 30 minutes
- 1 hour
- 2 hours
- 4 hours
- 6 hours
- 8 hours
Secondary outcome [1] 420514 0
Peripheral blood pressure using either automated blood pressure cuff or sphymomanometer
Timepoint [1] 420514 0
Time points post dose
- 30min
- 60min
- 90min
- 2 hours
- 3 hours
- 4 hours
- 6 hours
- 8 hours
Secondary outcome [2] 420516 0
Fetal monitoring via cardiotocograph (CTG)
Timepoint [2] 420516 0
Time points post dose
- From dose until 30min
- 2 hours post-dose
Secondary outcome [3] 420518 0
Liver function testing with blood analysis
Timepoint [3] 420518 0
Time points post dose
- 2-hours
- 8-hours

Eligibility
Key inclusion criteria
Group 1: Healthy, non-pregnant women
• Not pregnant.
• Deemed capable of understanding the information provided and able to give written informed consent (with interpreter use as required).
• Body mass index (BMI) between 18 – 35kg/m2.
• Greater than or equal to 18 years of age

Group 2: Healthy, pregnant women
• Singleton pregnancy.
• Gestation between 28+0 and 36+0 weeks pregnant.
• Normal mid-trimester morphology scan, with no detectable significant anomalies.
• Deemed capable of understanding the information provided and able to give written informed consent (with interpreter use as required).
• Booking body mass index (BMI) between 18 – 35kg/m2.
• Greater than or equal to 18 years of age

Group 3: Pregnant women with a hypertensive disorder of pregnancy
• Singleton pregnancy.
• Gestation between 28+0 and 36+0 weeks pregnant.
• Diagnosis of hypertension in pregnancy or preeclampsia
• Deemed capable of understanding the information provided and able to give written informed consent (with interpreter use as required).
• Booking body mass index (BMI) between 18 – 35kg/m2.
• Greater than or equal to 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Group 1: Healthy, non-pregnant women
Participant exclusion criteria:
• < 18 years of age.
• Body mass index (BMI) < 18 or > 35kg/m2.
• Confirmed or suspected pregnancy.
• Current use of broccoli sprout extract supplement.
• Contraindications to use (e.g., intolerance of broccoli).
• Significant uncertainty in ensuring gestational age is within limits.
• Unwillingness or inability to follow the procedures outlined in the PI and CF.
• Mentally, cognitively or legally incapacitated or ineligible to provide informed consent.
• Co-recruitment/participation in another clinical trial where there is a pharmaceutical or herbal or nutritional intervention (such trial interventions would also include: multi-vitamins, minerals, complementary and alternative medicines).

Group 2: Healthy, pregnant women
Participant exclusion criteria:
• Nil major complications of pregnancy including but not limited to:
o Fetal growth restriction estimated fetal weight <10th centile or AC (abdominal circumference) <5th
o Preeclampsia/HELLP syndrome (haemolysis elevated liver enzymes low platelet syndrome)
o Gestational diabetes on insulin on >20units insulin/day
o PPROM (preterm pre-labour rupture of membranes) within 7 days ago
o Chorioamnionitis
o Stillbirth or intrauterine fetal death
o Suspected or confirmed congenital infection of pregnancy (i.e. CMV, syphilis, rubella)
o Unstable major placenta praevia or vasa praevia
o Hypertensive disorder of pregnancy on >1 regular anti-hypertensive treatment
o Abnormal umbilical artery doppler i.e. elevated umbilical artery doppler pulsatility index (UA PI >95th), absent end-diastolic flow or reversal of end-diastolic flow, or a reduced middle cerebral artery pulsatility index (MCA PI <5th) or abnormal ductus venosus (DV)
• Renal or hepatic dysfunction.
• Current use of broccoli sprout extract supplement.
• Contraindications to use (e.g., intolerance of broccoli).
• Significant uncertainty in ensuring gestational age is within limits.
• Unwillingness or inability to follow the procedures outlined in the PI and CF.
• Mentally, cognitively or legally incapacitated or ineligible to provide informed consent.
• Co-recruitment/participation in another clinical trial where there is a pharmaceutical or herbal or nutritional intervention (such trial interventions would also include: multi-vitamins, minerals, complementary and alternative medicines).

Group 3: Pregnant women with a hypertensive disorder of pregnancy
Participant exclusion criteria:
• Nil major complications of pregnancy including but not limited to:
o Fetal growth restriction estimated fetal weight <10th centile or AC (abdominal circumference) <5th
o Gestational diabetes on insulin on >20units insulin/day
o PPROM (preterm pre-labour rupture of membranes) within 7 days ago
o Chorioamnionitis
o Stillbirth or intrauterine fetal death
o Suspected or confirmed congenital infection of pregnancy (i.e. CMV, syphilis, rubella)
o Unstable major placenta praevia or vasa praevia
o Abnormal umbilical artery doppler i.e. elevated umbilical artery doppler pulsatility index (UA PI >95th), absent end-diastolic flow or reversal of end-diastolic flow, or a reduced middle cerebral artery pulsatility index (MCA PI <5th) or abnormal ductus venosus (DV)
• Eclampsia
• Current use of broccoli sprout extract supplement.
• Contraindications to use (e.g., intolerance of broccoli).
• Significant uncertainty in ensuring gestational age is within limits.
• Unwillingness or inability to follow the procedures outlined in the PI and CF.
• Mentally, cognitively or legally incapacitated or ineligible to provide informed consent.
• Co-recruitment/participation in another clinical trial where there is a pharmaceutical or herbal or nutritional intervention (such trial interventions would also include: multi-vitamins, minerals, complementary and alternative medicines).

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



Intervention assignment
Parallel
Other design features
Nil
Phase
Phase 0
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
A convenience n-number of 6 has been used based on previous work investigating sulforaphane concentrations in pregnant individuals. Demographics will be reported as median and IQR (25th to 75th centile). Paired t-test will be used if normally distributed pharmacokinetic outcomes to determine statistical significance (p < 0.05). Time to maximum concentration (T max) is presented as median and range and tested with Wilcoxon rank-sum test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/06/2023
Actual
26/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 40079 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 313574 0
University
Name [1] 313574 0
Monash University
Country [1] 313574 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
Clayton
VIC 3168
Country
Australia
Secondary sponsor category [1] 315382 0
None
Name [1] 315382 0
Address [1] 315382 0
Country [1] 315382 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312755 0
Monash Health Human Research and Ethics Committee
Ethics committee address [1] 312755 0
246 Clayton Road
Clayton
VIC 3168
Ethics committee country [1] 312755 0
Australia
Date submitted for ethics approval [1] 312755 0
25/11/2022
Approval date [1] 312755 0
24/07/2023
Ethics approval number [1] 312755 0
RES-22-0000-732A

Summary
Brief summary
Sulforaphane is a naturally occurring organophosphur able to upregulate phase II detoxification enzymes resulting in anti-inflammatory and antioxidant effects. Sulforaphane has been widely investigated outside of pregnancy in a wide variety of clinical trials including cancer, autism spectrum disorder and gastroesophageal reflux disease.

Sulforaphane is generally administered in the form of glucurophanin via broccoli sprout supplements and has variable formulations and manufacturing pathways. It is hypothesised that sulforaphane will provide beneficial effects to various pathological states of pregnancy. It is important to compare the various formulations of sulforaphane commercially available to inform decisions for clinical trial design and analysis of sulforaphane trial outcomes. This study will compare three different commerically available broccoli sprout extracts and their circulating concentrations in healthy pregnant participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125790 0
A/Prof Kirsten Palmer
Address 125790 0
Monash Medical Centre
246 Clayton Road
CLAYTON
VIC 3168
Country 125790 0
Australia
Phone 125790 0
+61 3 9594 5145
Fax 125790 0
Email 125790 0
[email protected]
Contact person for public queries
Name 125791 0
Sarah Marshall
Address 125791 0
The Ritchie Centre
27–31 Wright Street
Clayton VIC 3168
Country 125791 0
Australia
Phone 125791 0
+61 3 9594 5145
Fax 125791 0
Email 125791 0
[email protected]
Contact person for scientific queries
Name 125792 0
Sarah Marshall
Address 125792 0
The Ritchie Centre
27–31 Wright Street
Clayton VIC 3168
Country 125792 0
Australia
Phone 125792 0
+61 3 9594 5145
Fax 125792 0
Email 125792 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual patient data after publication will be shared following application to the chief investigator. Results will be deidentified and provided for circulating concentration of sulforaphane and metabolites after approval.
When will data be available (start and end dates)?
Following publication of the study results with no end date
Available to whom?
Will be made accessible following application to the chief principal investigator and with approval.
Available for what types of analyses?
Primary outcome pharmacokinetic results of sulforaphane and metabolites.
How or where can data be obtained?
Via contact to the study chief principal investigator A/Prof Kirsten Palmer on email [email protected] or Dr Sarah Marshall [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.