Comparison of broccoli sprout extracts in non-pregnant and pregnant wome

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 56

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:
• major complications of pregnancy including but not limited to:
oFetal growth restriction estimated fetal weight <10th centile or AC (abdominal circumference) <5th
oPreeclampsia/HELLP syndrome (haemolysis elevated liver enzymes low platelet syndrome)
oGestational diabetes on insulin on >20units insulin/day
oPPROM (preterm pre-labour rupture of membranes) within 7 days ago
oChorioamnionitis
oStillbirth or intrauterine fetal death
oSuspected or confirmed congenital infection of pregnancy (i.e. CMV, syphilis, rubella)
oUnstable major placenta praevia or vasa praevia
oHypertensive disorder of pregnancy on >1 regular anti-hypertensive treatment
oAbnormal 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:
• major complications of pregnancy including but not limited to:
oFetal growth restriction estimated fetal weight <10th centile or AC (abdominal circumference) <5th
oGestational diabetes on insulin on >20units insulin/day
oPPROM (preterm pre-labour rupture of membranes) within 7 days ago
oChorioamnionitis
oStillbirth or intrauterine fetal death
oSuspected or confirmed congenital infection of pregnancy (i.e. CMV, syphilis, rubella)
oUnstable major placenta praevia or vasa praevia
oAbnormal 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 ag

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circulating concentration of sulforaphane and metabolites with blood sample analysis <br><br>[ Time points post-dose <br>- 30 minutes <br>- 1 hour <br>- 2 hours<br>- 4 hours <br>- 6 hours<br>- 8 hours<br>]

Secondary Outcome Measures

Name	Time	Method
Peripheral blood pressure using either automated blood pressure cuff or sphymomanometer[ Time points post dose<br>- 30min<br>- 60min<br>- 90min<br>- 2 hours<br>- 3 hours<br>- 4 hours<br>- 6 hours<br>- 8 hours];Fetal monitoring via cardiotocograph (CTG)[ Time points post dose<br>- From dose until 30min<br>- 2 hours post-dose];Liver function testing with blood analysis [ Time points post dose<br>- 2-hours <br>- 8-hours]