The pharmacokinetics of two natural broccoli sprout supplements in healthy adults.

Evaluating the human pharmacokinetics (PK) of Sulforaphane from natural broccoli sprout supplements, a prospective, open label, exploratory cross over trial in healthy adults.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000567325

Enrollment

Registered

2017-04-24

Start date

2017-05-11

Completion date

2019-06-24

Last updated

2018-06-11

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, antiinflammatory effects of Sulforaphane and its ability to protect against endothelial dysfunction and end organ damage. Therefore, we believe Sulforaphane may have a potential clinical utilitity 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 two different natural broccoli sprout supplements in a healthy cohort of subjects n=6. Participation involves the ingestion of each of the two different supplements with associated PK blood sampling at 8 pre-determined time points, one just prior to ingestion and then following at: 15, 30, 60, 90, 120, 240 and 480 minutes intervals. The study is an open-label, crossover design, with a two week ‘wash out’ period, between taking the first supplement and the second (different) supplement.

Interventions

The first supplement to be taken by all participants will be: 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 Following the ingestion of this first supplement, there will be a 2 week 'wash out' period.

Study design

Allocation

Non-randomised trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1) Healthy (defined as, no requirement for regular medication(s) and/or under the care of GP or hospital, for the treatment of an ongoing condition). 2) Adults, aged between 18-55 years old.

Exclusion criteria

1) Pregnant, or planning a pregnancy 2) Taking any nutritional supplement(s) 3) Using hormonal contraception or hormone replacement therapy (HRT).

Outcome results