Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001296123
Ethics application status
Approved
Date submitted
6/06/2019
Date registered
19/09/2019
Date last updated
19/09/2019
Date data sharing statement initially provided
19/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of Milk Thistle extract (Silibinin) On circulating unconJugated bilirubin levels and markers for Oxidative stress and inflammation: MOJO study
Scientific title
Effect of Milk Thistle extract (Silibinin) On circulating unconJugated bilirubin levels and markers for Oxidative stress and inflammation in healthy volunteers.
Secondary ID [1] 298433 0
None
Universal Trial Number (UTN)
Trial acronym
MOJO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxidative stress and Inflammation 313170 0
Cardiovascular Disease 313313 0
Condition category
Condition code
Cardiovascular 311632 311632 0 0
Other cardiovascular diseases
Alternative and Complementary Medicine 312849 312849 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1 capsule, 3 times a day of Legalon (equivalent of 140mg silimarin) for 14 days with crossover to placebo.
Washout period between cross over of (28 days (males) or 42 days (females).
Compliance will be measured by a pill count at end of each study arm.
Intervention code [1] 314682 0
Treatment: Other
Comparator / control treatment
crossover study with active and placebo,
Placebo treatment contains mannitol which is the same dispersant used in the active
Control group
Placebo

Outcomes
Primary outcome [1] 320329 0
Change in circulating total bilirubin levels (>5µM). This will be done through assessment of free and conjugated plasma bilirubin.
Timepoint [1] 320329 0
14 days after starting each intervention arm
Secondary outcome [1] 371263 0
Change in antioxidant status (Ferric Reducing Ability of plasma),
Timepoint [1] 371263 0
14 days
Secondary outcome [2] 371453 0
plasma Inflammation (hsCRP),
Timepoint [2] 371453 0
14 days
Secondary outcome [3] 371454 0
plasma lipid profile (LDL:HDL ratio / profile)
Timepoint [3] 371454 0
14 days
Secondary outcome [4] 371455 0
platelet aggregation
Timepoint [4] 371455 0
14 days
Secondary outcome [5] 371456 0
plasma Uric acid levels
Timepoint [5] 371456 0
14 days

Eligibility
Key inclusion criteria
1. Adults of any gender between the age of 18 and 65
2. Normal Liver Function result (LFT)
3. Normal Full Blood count (FBC)
4. Random Fasting Blood Glucose level (3.0-7.7 mmol/L.)
5. BMI between 18.5 -29.9
6. Are not pregnant or breast feeding
7. Able to give informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of Liver Disease
2. History of Alcohol abuse
3. History of Type II Diabetes
4. A history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will occur through the selection of a sealed opaque envelopes that will contain a number. This number will correspond to a medication pack. Patients will be randomised to one of two treatment groups in equal proportion
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised to one of two treatment groups in equal proportion, crossover after 14 days with washout period dependent on gender (28 days for males; 42 days for females). Capsules for active and placebo are colour matched.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Both the Primary and Secondary Outcomes will be analysed with respect to a change from baseline using Analysis of Variance (ANOVA).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
30
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 302983 0
University
Name [1] 302983 0
Endeavour College of Natural Health
Country [1] 302983 0
Australia
Primary sponsor type
University
Name
Endeavour College of Natural Health
Address
105 Scarborough Street, Southport, Queensland, 4215, Australia
Country
Australia
Secondary sponsor category [1] 302940 0
None
Name [1] 302940 0
None
Address [1] 302940 0
Country [1] 302940 0
Other collaborator category [1] 280730 0
University
Name [1] 280730 0
Griffith University
Address [1] 280730 0
Parklands Dr
Southport, Qld
4215
Country [1] 280730 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303533 0
Griffith University HREC
Ethics committee address [1] 303533 0
Parklands Dr
Southport, Qld
4215
Ethics committee country [1] 303533 0
Australia
Date submitted for ethics approval [1] 303533 0
10/02/2017
Approval date [1] 303533 0
27/07/2017
Ethics approval number [1] 303533 0
2017/173

Summary
Brief summary
Milk Thistle has been used in medical remedies for 2000 years as a therapeutic herbal medicine in the treatment of acute and chronic liver diseases. Some of its effects have been shown to due to an antioxidant and anti-inflammatory effect. There is also evidence that an active constituent within Milk Thistle called Silibinin inhibits an enzyme that works on the bile pigment called bilirubin which allows its excretion from the body. Inhibition of this enzyme would allow bilirubin levels to rise to produce a condition called ‘mild hyperbilirubinemia’. Many clinical studies demonstrate a dramatic reduction in cardiovascular disease (CVD) and atherosclerosis in patients that is directly attributed to elevated bilirubin levels in the blood. This effect is in part due to the powerful anti-oxidant properties of bilirubin. The aim of this study is to see if taking Milk Thistle extract will increase bilirubin levels and over time, may provide protection from heart disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93994 0
Dr Michael Watson
Address 93994 0
Endeavour College of Natural Health
105 Scarborough Street, Southport, Queensland, 4215
Country 93994 0
Australia
Phone 93994 0
+61 7 5634 8492
Fax 93994 0
Email 93994 0
[email protected]
Contact person for public queries
Name 93995 0
Dr Michael Watson
Address 93995 0
Endeavour College of Natural Health
105 Scarborough Street, Southport, Queensland, 4215
Country 93995 0
Australia
Phone 93995 0
+61 7 5634 8492
Fax 93995 0
Email 93995 0
[email protected]
Contact person for scientific queries
Name 93996 0
Dr Michael Watson
Address 93996 0
Endeavour College of Natural Health
105 Scarborough Street, Southport, Queensland, 4215
Country 93996 0
Australia
Phone 93996 0
+61 7 5634 8492
Fax 93996 0
Email 93996 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseEffect of Silymarin Treatment on Circulating Bilirubin and Cardiovascular Disease Risk Factors in Healthy Men: A Single-Blind, Randomized Crossover Trial.2021https://dx.doi.org/10.1002/cpdd.962
N.B. These documents automatically identified may not have been verified by the study sponsor.