Effect of Milk Thistle extract (Silibinin) On circulating unconJugated bilirubin levels and markers for Oxidative stress and inflammation: MOJO study

Effect of Milk Thistle extract (Silibinin) On circulating unconJugated bilirubin levels and markers for Oxidative stress and inflammation in healthy volunteers.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001296123

Acronym

MOJO

Enrollment

Registered

2019-09-19

Start date

2017-12-01

Completion date

Unknown

Last updated

2019-09-30

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

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

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

Outcome results