RecruitingEarly Phase 1ACTRN12623000591651

Assessment of maternal-fetal transfer of sulforaphane and metabolites

Assessment of maternal-fetal transfer of sulforaphane and metabolites in umbilical cord blood and expressed breast milk


Sponsor

Monash Health

Enrollment

8 participants

Start Date

Jul 31, 2023

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Broccoli sprouts contain a compound called glucoraphanin that converts in the body to sulforaphane — a natural substance that activates antioxidant and anti-inflammatory pathways. Researchers are interested in whether sulforaphane could help protect babies from inflammation-related brain injury during pregnancy complications. Before larger trials can be run, it is important to know whether sulforaphane actually crosses the placenta to reach the baby. This study will give broccoli sprout extract to pregnant women who are having a planned caesarean section at term (37 weeks or later) and then measure sulforaphane levels in the mother's blood, the baby's cord blood, and expressed breast milk after delivery. You may be eligible if you are 18 or older, have a healthy singleton pregnancy, are planning an elective caesarean section after 37 weeks, and have had a normal mid-pregnancy ultrasound. You would not be eligible if you have had complications such as preeclampsia, gestational diabetes requiring insulin, fetal growth restriction, liver or kidney problems, or if you are already taking broccoli sprout supplements.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 el

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.


Locations(2)

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

Jessie McPherson Private Hospital - Clayton

VIC, Australia

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ACTRN12623000591651


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