Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000567325
Ethics application status
Approved
Date submitted
19/04/2017
Date registered
24/04/2017
Date last updated
25/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The pharmacokinetics of two natural broccoli sprout supplements in healthy adults.
Scientific title
Evaluating the human pharmacokinetics (PK) of Sulforaphane from natural broccoli sprout supplements, a prospective, open label, exploratory cross over trial in healthy adults.
Secondary ID [1] 291688 0
Nil Known
Universal Trial Number (UTN)
U1111-1195-4406
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacokinetic study of a nutritional supplement in healthy adults, as a potential future therapy for the treatment of pre-eclampsia. 302859 0
Condition category
Condition code
Reproductive Health and Childbirth 302340 302340 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 297780 0
Treatment: Other
Comparator / control treatment
Once the 2 week 'wash out' period has been completed, the second supplement to be taken by all participants will be:
Supplement name: Broccoli Sprouts Extract
Manufacturer: Source Naturals
Standardised extract yielding 1,000 micrograms (mcg) of sulforaphane per tablet
1) Single dose (2 tablets)
2) The mode of administration: oral
Control group
Active

Outcomes
Primary outcome [1] 301765 0
The primary outcome of the trial is to ascertain the serum level of Sulforaphane following the ingestion of two different preparations of broccoli sprout supplements in healthy adults.

Pharmacokinetic parameters include: Absolute bioavailability (F), absorption rate constant, (Ka), clearance (Cl) and volume of distribution (Vd). Bioanalysis and modelling will be used to determine maximum plasma concentration (Cmax), time to Cmax (Tmax), area under the plasma concentration-time curve (AUC) and terminal phase half-life (t 1/2).
Timepoint [1] 301765 0
Blood samples will be collected from participants for pharmacokinetic (PK) analysis: before ingestion of the supplement (5 minutes, or less) and then following ingestion of the supplement, at a 'desired' seven further targeted time points of: 15 (+/-5) minutes, 30 (+/-5) minutes, 60 (+/-5) minutes, 90 (+/-5) minutes, 120 (+/-15) minutes, 240 (+/-15) minutes, 480 (+/-15) minutes.
Secondary outcome [1] 333797 0
The secondary outcome of the trial is to determine if there is a difference in the serum levels of Sulforaphane between the two different preparations of broccoli sprout supplements in healthy adults.
Timepoint [1] 333797 0
Blood samples will be collected from participants for pharmacokinetic (PK) analysis: before ingestion of the supplement (5 minutes, or less) and then following ingestion of the supplement, at a 'desired' seven further targeted time points of: 15 (+/-5) minutes, 30 (+/-5) minutes, 60 (+/-5) minutes, 90 (+/-5) minutes, 120 (+/-15) minutes, 240 (+/-15) minutes, 480 (+/-15) minutes.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Pregnant, or planning a pregnancy
2) Taking any nutritional supplement(s)
3) Using hormonal contraception or hormone replacement therapy (HRT).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not Applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not Applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
The study is an exploratory study to obtain Pk data related to the ingestion of broccoli sprout supplements, the n=6 participants (3 female and 3 male) was chosen based on the data available from previous, similar studies.

Participant demographic data will be assessed for normality. Characteristics of the two groups will be tabulated and compared using the appropriate statistical test (e.g. Chi 2, independent t-test, Mann-Whitney test). Nonparametric data will be expressed as median and interquartile range (IQR). A p-value <0.05 (two-tailed) will be regarded as statistically significant. Data will be analysed using the SPSS statistical package (SPSS 24.0, IBM Corp, Armonk, New York, USA).

PK data will analysed by nonlinear mixed-effects modelling.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/04/2017
Actual
11/05/2017
Date of last participant enrolment
Anticipated
24/06/2019
Actual
Date of last data collection
Anticipated
24/06/2019
Actual
Sample size
Target
6
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7844 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 15784 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 296187 0
University
Name [1] 296187 0
Monash University
Country [1] 296187 0
Australia
Funding source category [2] 296200 0
Other
Name [2] 296200 0
The Hudson Institute of Medical Research, The Ritchie Centre
Country [2] 296200 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country
Australia
Secondary sponsor category [1] 295109 0
None
Name [1] 295109 0
Not Applicable
Address [1] 295109 0
Not Applicable
Country [1] 295109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297430 0
Monash Health, Human Research Ethics Committee
Ethics committee address [1] 297430 0
Monash Health Research Directorate
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Ethics committee country [1] 297430 0
Australia
Date submitted for ethics approval [1] 297430 0
06/04/2017
Approval date [1] 297430 0
28/04/2017
Ethics approval number [1] 297430 0

Summary
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.
Trial website
Not applicable
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74010 0
Prof Euan M. Wallace
Address 74010 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country 74010 0
Australia
Phone 74010 0
+61 3 9594 5145
Fax 74010 0
+61 3 9594 5003
Email 74010 0
[email protected]
Contact person for public queries
Name 74011 0
Ms Annie Cox
Address 74011 0
The Ritchie Centre, Hudson Institute of Medical Research and Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country 74011 0
Australia
Phone 74011 0
+61 3 9594 5145
Fax 74011 0
N/A
Email 74011 0
[email protected]
Contact person for scientific queries
Name 74012 0
Prof Euan M. Wallace
Address 74012 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country 74012 0
Australia
Phone 74012 0
+61 3 9594 5145
Fax 74012 0
+61 3 9594 5003
Email 74012 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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