Pharmacokinetics of Sulforaphane from Natural Broccoli Sprout Supplements in Pregnancy.

Pharmacokinetics of Sulforaphane from Natural Broccoli Sprout Supplements in Pregnancy: a prospective, open label trial.

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001100381

Enrollment

Registered

2017-07-28

Start date

2019-02-04

Completion date

2019-12-31

Last updated

2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Sulforaphane is a naturally occurring compound belonging to the isothiocyanate group. It can be obtained naturally through cruciferous vegetables with broccoli sprouts being one of the richest sources. Sulforaphane obtained through ingested broccoli sprouts are activated by myrosinase, a chemical that is released by chewing of the vegetable. Myrosinase is also present in the gut flora of individuals and mediates the conversion of precursor compound to bioavailable sulforaphane. Previous studies in humans has demonstrated the antioxidative, anti-inflammatory effects of Sulforaphane and its ability to protect against endothelial dysfunction and end organ damage. Therefore, we believe sulforaphane may have a potential clinical utility in maternity care as a ‘low risk’ intervention for the treatment of pre-eclampsia. The aim of the research project is to evaluate the pharmacokinetics (PK) of sulforaphane obtained through the ingestion of a natural broccoli sprout supplement in a cohort of healthy women 24-36 weeks pregnant with one baby, n=6 Participation involves the ingestion of two tablets (together) of the broccoli sprout supplement with associated PK blood sampling at nine pre-determined time points, one just prior to ingestion of the supplement and then following at: 15, 30, 60, 90, 120, 240, 480, 720 minute intervals.

Interventions

All participants will be administered: Supplement name: BroccoMax Broccoli Seed Extract (Myrosinase activated) . Delayed release. Manufacturer: Jarrow Formulas Sulforaphane glucosinolate content 30mg per tablet (capsule) 1) Single dose (2 capsules) 2) The mode of administration: oral

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 55 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy, pregnant with a singleton fetus between 24 to 36 weeks gestation. Able to read and understand the Patient Information and Consent Form, and to provide written, informed consent.

Exclusion criteria

Pregnant women who are taking a medication, or who have a medical or pregnancy related condition, that may have the potential to interfere with the pharmacokinetics of the broccoli sprout supplement.

Outcome results