Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000812594p
Ethics application status
Not yet submitted
Date submitted
17/06/2024
Date registered
2/07/2024
Date last updated
2/07/2024
Date data sharing statement initially provided
2/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the effects of a broccoli sprout extract on flow-mediated dilation
Scientific title
Assessing the effects of a broccoli sprout extract on endothelial function in healthy non-pregnant and pregnant women, and pregnant women with a hypertensive disorder of pregnancy
Secondary ID [1] 312345 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypertension in pregnancy 334115 0
Condition category
Condition code
Reproductive Health and Childbirth 330789 330789 0 0
Fetal medicine and complications of pregnancy
Cardiovascular 330869 330869 0 0
Hypertension
Alternative and Complementary Medicine 330870 330870 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will consume a single dose of a commercially available broccoli sprout extract with supervision by research staff. The extract is detailed below:
- 2 capsules of GeneActiv Formulation E by Cell-Logic - 1400mg broccoli sprout supplement total sulforaphane dose 21mg.
Intervention code [1] 328833 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338550 0
Change in endothelial function after a single dose of a broccoli sprout extract in women.
Timepoint [1] 338550 0
Before (baseline) and 2-3 hours after consumption of the intervention.
Secondary outcome [1] 436448 0
Concentration of sulforaphane in peripheral maternal blood sample.
Timepoint [1] 436448 0
2-3 hours after consumption of the intervention.
Secondary outcome [2] 436449 0
Measure any change in blood pressure from baseline after intervention.
Timepoint [2] 436449 0
Before (baseline) and 2-3 hours after consumption of the intervention.

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.
• 18 years old and over

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 and 35kg/m2.
• 18 years old and over.

Group 3: Pregnant women with a hypertensive disorder of pregnancy
• Singleton pregnancy
• Gestation between 28+0 and 36+6 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 and 35kg/m2.
• 18 years old and over.
• Diagnosis of preeclampsia or clinical hypertension as defined by the according to the Society of Obstetric Medicine of Australia and New Zealand (SOMANZ) guidelines.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Group 1: Healthy, non-pregnant women
• Younger than 18 years old
• 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 PICF.
• 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
• 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 PICF.
• 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
• 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 PICF.
• 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
1/11/2026
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26692 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 26693 0
Jessie McPherson Private Hospital - Clayton
Recruitment postcode(s) [1] 42733 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 316746 0
University
Name [1] 316746 0
Monash University
Country [1] 316746 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Country
Australia
Secondary sponsor category [1] 318962 0
None
Name [1] 318962 0
Address [1] 318962 0
Country [1] 318962 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 315517 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 315517 0
Ethics committee country [1] 315517 0
Australia
Date submitted for ethics approval [1] 315517 0
01/08/2024
Approval date [1] 315517 0
Ethics approval number [1] 315517 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134950 0
Dr Sarah Marshall
Address 134950 0
Translational Research Facility, Monash University/Monash Health, 27-31 Wright Street Clayton 3168, Victoria
Country 134950 0
Australia
Phone 134950 0
+61 385722792
Fax 134950 0
Email 134950 0
[email protected]
Contact person for public queries
Name 134951 0
Sarah Marshall
Address 134951 0
Translational Research Facility, Monash University/Monash Health, 27-31 Wright Street Clayton 3168, Victoria
Country 134951 0
Australia
Phone 134951 0
+61 385722792
Fax 134951 0
Email 134951 0
[email protected]
Contact person for scientific queries
Name 134952 0
Sarah Marshall
Address 134952 0
Translational Research Facility, Monash University/Monash Health, 27-31 Wright Street Clayton 3168, Victoria
Country 134952 0
Australia
Phone 134952 0
+61 385722792
Fax 134952 0
Email 134952 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data collection from individuals will be combined to have meaningful outcomes. An individuals data will not be made available but results will be published in a non-identifiable manner after completion of the project.


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.