Assessing the effects of a broccoli sprout extract on flow-mediated dilatio

Not Applicable

• Conditions: hypertension in pregnancy; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Cardiovascular - Hypertension; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12624000812594
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-02
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 30

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
• 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 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
• 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 age is within limits.
•Unwillingness or inability to follow the procedures outlined in the PICF.
•Me

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in endothelial function after a single dose of a broccoli sprout extract in women.[Ultrasound scans of Flow-Mediated Dilation of the brachial artery. Before (baseline) and 2-3 hours after consumption of the intervention.]

Secondary Outcome Measures

Name	Time	Method
Concentration of sulforaphane in peripheral maternal blood sample.[Liquid chromatography mass spectrometry. 2-3 hours after consumption of the intervention.];Measure any change in blood pressure from baseline after intervention.[Uscome BP+ supra-systolic oscillometric central blood pressure monitoring device Before (baseline) and 2-3 hours after consumption of the intervention.]