Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000692831
Ethics application status
Not yet submitted
Date submitted
27/06/2012
Date registered
28/06/2012
Date last updated
28/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Sulforaphane on the Vascular Status and Oxidative status of Type 2 Diabetes
Scientific title
Effect of a Sulforaphane-Yielding Encapsulated Product compared with Placebo on Arterial Stiffness and other Biochemical Markers in Type 2 Diabetics aged 18-45 years.
Secondary ID [1] 280742 0
Nil
Universal Trial Number (UTN)
U1111-1132-1654
Trial acronym
EASY DIAB 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 286788 0
Condition category
Condition code
Metabolic and Endocrine 287101 287101 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ECB capsules each contain 700mg of 100% Myrosinase-active Broccoli Sprout powder. Participants will take 3 capsules night and morning for 26 weeks. All participants will be required to avoid eating cruciferous vegetables because phytochemicals in these foods may activate some of the same pathways as the capsule's active ingredient.
Intervention code [1] 285168 0
Treatment: Drugs
Comparator / control treatment
Double-blinded, randomised, placebo-controlled, using a 2-piece gel capsule containing colour-matched maltodextrin, identical in appearance to the active product. All participants will be required to avoid eating cruciferous vegetables because phytochemicals in these foods may activate some of the same pathways as the capsule's active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 287422 0
CLINICAL MARKER: Arterial Stiffness as measured via Pulse Wave Velocity (PWV) using applanation tonometry (SphygmoCor). The procedure will be performed at rest at the Royal Brisbane & Women's Hospital, Herston Qld 4029.
Timepoint [1] 287422 0
To be measured at 13 weeks and 26 weeks
Primary outcome [2] 287423 0
BIOCHEMICAL MARKER 1: Leukocyte Quinone reductase. Fasting blood samples will be taken a portion allocated for extraction of leukocytes for analysis of gene expression via Northern Blot Analysis.

BIOCHEMICAL MARKER 2: Ratio of oxidised:reduced glutathione. Plasma erythrocytes will be assayed using the automated COBAS spectrophotometric Analyser at the University of Queensland, School of Human Movement Studies Oxidative Stress Laboratory.
Timepoint [2] 287423 0
To be measured at 13 weeks and 26 weeks
Secondary outcome [1] 298109 0
Blood pressure will be measured after the participant rests for 10 minutes in a seated position and using an automatic sphygmomanometer.
Timepoint [1] 298109 0
To be measured at 13 weeks and 26 weeks
Secondary outcome [2] 298112 0
BIOCHEMICAL MARKERS: Markers of oxidative stress. The Oxidative Stress Laboratory in the School of Human Movement Studies at the University of Queensland routinely measures antioxidnt enzymes, cytokines, malondialdehyde and F2-isoprostanes using ant automated COBAS Spectrophotometric Analyser
Timepoint [2] 298112 0
To be measured at 13 weeks and 26 weeks

Eligibility
Key inclusion criteria
Medically-diagnosed with Type 2 diabetes without disease complications. Medication schedule must have been stable for at least 6 months and is not expected to change within the next 6 months. Must be able to attend the research clinic on 4 separate occasions over the 6 month-period of the trial. Must be prepared to take 6 plant-based capsules daily and refrain from eating cruciferous vegetables
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Evident diabetic complications such as retinopathy, neuropathy and nephropathy. Those whose diabetic condition requires regular insulin. Smokers and those using recreational drugs. Males conusming more than 4 alcoholic drinks and females consuing more than 2 alcoholic drinks daily. Those with BMI > 30 or < 20.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Research group personnel will determine eligibility based on the Inclusion and Exclusion criteria. Following return of signed Informed Consent, each of the 82 eligible participants will be appropriately code numbered and the codes sent to the Royal Brisbane & Women's Hospital Pharmacy where randomisation will be performed. The Research personnel who determine eligibility will have no contact at any time with the pharmacy where randomisation will be performed. The capsules (both active and placebo) will be dispensed in identical dosette containers named for the study and identified only by a code number from 1-82.

Randomisation codes will be placed in sequentially numbered, opaque, heat sealed envelopes and will be kept in two separate locations: one copy in the office of Professor Coombes at the University of Queensland and the second copy in the office of Professor Robert Fassett at the Royal Brisbane & Womens' Hospital in Brisbane.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation and concealment will be handled by the Pharmacy Department at the Royal Brisbane & Womens' Hospital and will be conducted according to protocols suggested in the CONSORT Statement Items 8a- 11a. Randomisation will be used to avoid bias in the
assignment of subjects to the nature of the capsule, to increase the likelihood that known and unknown
subject attributes (e.g. demographics and baseline characteristics) are evenly balanced across groups, and
to enhance the validity of statistical comparisons across treatment groups. A simple randomisation process will be employed, using a randomisation table from a statistics book.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5420 0
4000
Recruitment postcode(s) [2] 5421 0
4005
Recruitment postcode(s) [3] 5422 0
4010
Recruitment postcode(s) [4] 5423 0
4015
Recruitment postcode(s) [5] 5424 0
4020
Recruitment postcode(s) [6] 5425 0
4025
Recruitment postcode(s) [7] 5426 0
4030
Recruitment postcode(s) [8] 5427 0
4035
Recruitment postcode(s) [9] 5428 0
4040
Recruitment postcode(s) [10] 5429 0
4045
Recruitment postcode(s) [11] 5430 0
4050
Recruitment postcode(s) [12] 5431 0
4055
Recruitment postcode(s) [13] 5432 0
4060
Recruitment postcode(s) [14] 5433 0
4065
Recruitment postcode(s) [15] 5434 0
4070
Recruitment postcode(s) [16] 5435 0
4075
Recruitment postcode(s) [17] 5436 0
4080
Recruitment postcode(s) [18] 5437 0
4085
Recruitment postcode(s) [19] 5438 0
4090
Recruitment postcode(s) [20] 5439 0
4095
Recruitment postcode(s) [21] 5440 0
4100
Recruitment postcode(s) [22] 5441 0
4105
Recruitment postcode(s) [23] 5442 0
4110
Recruitment postcode(s) [24] 5443 0
4115
Recruitment postcode(s) [25] 5444 0
4120
Recruitment postcode(s) [26] 5445 0
4125
Recruitment postcode(s) [27] 5446 0
4130
Recruitment postcode(s) [28] 5447 0
4135
Recruitment postcode(s) [29] 5448 0
4140
Recruitment postcode(s) [30] 5449 0
4145
Recruitment postcode(s) [31] 5450 0
4150

Funding & Sponsors
Funding source category [1] 285526 0
Hospital
Name [1] 285526 0
Royal Brisbane & Women's Hospital
Country [1] 285526 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Human Movement Studies
St Lucia Brisbane Qld 4072
Country
Australia
Secondary sponsor category [1] 284366 0
Commercial sector/Industry
Name [1] 284366 0
Cell-Logic Pty Ltd
Address [1] 284366 0
Brisbane Technology Park
7 Clunies Ross Court
Eight Mile Plains Qld 4113
Country [1] 284366 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287547 0
Medical Research Ethics Committee (MREC)
Ethics committee address [1] 287547 0
Ethics Officer
Research & Innovation Division
Cumbrae-Stewart Building (72)
THE UNIVERSITY OF QUEENSLAND QLD 4072
Ethics committee country [1] 287547 0
Australia
Date submitted for ethics approval [1] 287547 0
30/06/2012
Approval date [1] 287547 0
Ethics approval number [1] 287547 0

Summary
Brief summary
The prevalence of Type 2 diabetes and its complications is increasing globally. The condition is associated with lifestyle factors which impact biochemically at many levels. Markers of oxidative stress are typically elevated in the diabetic condition but attempts to regulate oxidative stress with antioxidant vitamins have been generally unsuccessful. The plant-derived capsules to be used in this trial yield a phytochemical, sulforaphane which has been shown to activate pathways leading to elevation of the cell's endogenous antioxidant enzymes and other cytoprotective compounds such as glutathione. This trial is aimed at testing the efficacy of such capsules in modifying the disease parameters associated with Type 2 diabetes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34368 0
Address 34368 0
Country 34368 0
Phone 34368 0
Fax 34368 0
Email 34368 0
Contact person for public queries
Name 17615 0
Professor Robert Fassett
Address 17615 0
Renal Research
Level 9, Ned Hanlon Building
Royal Brisbane & Women's Hospital
Herston Qld 4029
Country 17615 0
Australia
Phone 17615 0
+617 3636 2698
Fax 17615 0
+617 3636 8572
Email 17615 0
[email protected]
Contact person for scientific queries
Name 8543 0
Christine Houghton
Address 8543 0
School of Human Movement Studies
University of Queensland
Connell Building (26B)
St Lucia, 4072
Country 8543 0
Australia
Phone 8543 0
+617 3488 0385
Fax 8543 0
+617 3488 0389
Email 8543 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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