RecruitingEarly Phase 1ACTRN12623000592640

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

Comparing broccoli sprout supplement formulations for circulating sulforaphane concentration in non-pregnant and pregnant women


Sponsor

Monash Health

Enrollment

56 participants

Start Date

Jul 26, 2023

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Sulforaphane is a natural compound found in broccoli sprout supplements that may have anti-inflammatory and antioxidant benefits, including potential applications in pregnancy complications. However, different commercial broccoli sprout products vary widely in how they are made, meaning the amount of active sulforaphane that reaches the bloodstream can differ significantly between brands. This study will compare three commercially available broccoli sprout extract products to measure how much sulforaphane each one delivers into the blood, and whether this differs between non-pregnant women, healthy pregnant women, and pregnant women with a hypertensive disorder (such as pre-eclampsia). You may be eligible if you are female and 18 or older, and fall into one of three groups: a healthy non-pregnant woman; a healthy pregnant woman between 28 and 36 weeks; or a pregnant woman between 28 and 36 weeks who has been diagnosed with a hypertensive disorder of pregnancy. You would not be eligible if you currently take broccoli sprout supplements, have allergies to broccoli, have significant pregnancy complications beyond hypertension (for groups 2 and 3), or are enrolled in another nutrition-related clinical trial.

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

Three different commercially available broccoli sprout extracts will be compared for their circulating concentration of sulforaphane. Participants will be enrolled into groups sequentially until alloc

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


Locations(1)

VIC, Australia

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