None listed
Conditions
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.
Interventions
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 26.1m
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
Sponsors
Monash Health
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
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. • 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
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).
Outcome results
None listed