None listed
Conditions
Brief summary
Broccoli sprout extracts contain glucurophanin which converts into a compound called sulforaphane. Sulforaphane is a natural inducer of nuclear related ECH-like related factor 2 (Nrf2) activity which promotes production of endogenous anti-oxidant enzymes and anti-inflammatory cytokines. Numerous disorders of pregnancy result in states of oxidative stress and inflammation including fetal growth restriction and preeclampsia with risks of resultant neuroinflammation on the fetus and possibly adverse neurodevelopment. This study aims to investigate the possibility of sulforaphane transfer via the placenta and in expressed breast milk.
Interventions
Two capsules of broccoli sprout extract GeneActiv Formulation E by Cell-Logic (1400mg)
Total sulforaphane dose 21mg
Two doses per trial participant
Dose 1 - At least 2 hours prior to planned elective caesarean section
Dose 2 - At least 2 hours prior to planned breast feed on post-natal day 2 or 3
Participants will be observed at the time of capsule consumption for compliance at both time points for the two doses.
Sponsors
Monash Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Singleton pregnancy. - Planned elective caesarean section. - Gestation greater than 37+0 weeks. - 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). - Greater than or equal to 18 years of age.
Exclusion criteria
- Major complications of pregnancy including, but not limited to, fetal growth restriction, preeclampsia, gestational diabetes on insulin. - 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).
Outcome results
None listed