None listed
Conditions
Brief summary
Sulforaphane is a naturally occurring compound found in cruciferous vegetables such as broccoli, and has potent anti-inflammatory and antioxidant effects. Sulforaphane is administered in the form of broccoli sprout supplements as they're cheap, room temperature stable and have a proven safety profile in clinical trials outside of pregnancy including cancer and autism spectrum disorder. This trial will use non-invasive clinical methodologies to assess the vasculature in women both before and after a dose of a broccoli sprout extract. We would like to recruit up to 30 women for this trial (non-pregnant, pregnant, pregnant with hypertension) to assess blood pressure, collect one blood sample, and assess flow mediated dilation. This will assess whether a single dose of a broccoli sprout extract has immediate effects on the vasculature. We hypothesise that a single dose of a broccoli sprout extract will not affect blood pressure but will increase flow-mediated dilation in all non-pregnant and pregnant women.
Interventions
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.
Sponsors
Monash Health
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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).
Outcome results
None listed