Effect of Silibinin(A) as a Potential Anti-obesity Agent

Hypercholesterolemia Clinical Trial

Official title:

Effect of Milk Thistle Derivative Silibinin(A) as a Potential Anti-obesity Agent

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05069298
• Other study ID #: BIO-HPC_1
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: December 21, 2023

Study information

• Verified date: June 2023
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our preliminary reports have found in silico and in vitro that the milk thistle derivative Silibinin(A) is able to inhibit pancreatic lipase, in a similar way that the classical anti-obesity drug orlistat.

Therefore, the investigators want to carry out the present trial in order to confirm that Silibinin(A) is able to in vivo inhibit pancreatic lipase, which will reduce the fat absorption and therefore will decrease the amount of energy from food intake.

Considering that milk thistle has been extensively studied in humans as liver-protector, the investigators consider that the use of human subjects will be of great interest to accelerate the employment of this compound to improve the effectiveness of dietary treatment in overweight/obese subjects.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 21, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI > 24,9

• Voluntarily participate in the study

Exclusion Criteria:

• significant cognitive impairment

• psychiatric disorders

• chronic pharmacological treatment that may affect the effectiveness of the dietary intervention (corticosteroids, thyroid hormones, oral antidiabetic agents or lipid-lowering drugs)

• chronic disease that may interfere with dietary therapy (cancer, renal or hepatic impairment, chronic gastrointestinal conditions)

• acute disease episodes during the study

• subjects who followed a hypocaloric diet at the allocation time or in the 3 months prior to the beginning of the study

• pregnant women

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypertriglyceridemia
• Obesity
• Overweight
• Overweight and Obesity

Intervention

Dietary Supplement:
• Silibinin A
The compound will be administered following a 300 mg / 3 day schedule, before each main meal.

Locations

Country	Name	City	State
Spain	Faculty of Nursing. Catholic University of Murcia	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of total body weight loss	Change in body weight from baseline to the end of study period (3 months).	3 months
Secondary	Plasma total cholesterol	Change in plasma total cholesterol levels from baseline to the end of study period (3 months).	3 months
Secondary	Plasma low density level cholesterol (cLDL)	Change in plasma cLDL levels from baseline to the end of study period (3 months).	3 months
Secondary	Plasma triglycerides	Change in plasma triglyceride levels from baseline to the end of study period (3 months).	3 months
Secondary	Body mass index (BMI)	Change in BMI from baseline to the end of study period.	3 months
Secondary	Body fat percentage	Change in body fat from baseline to the end of study period.	3 months
Secondary	Waist circumference	Change in waist circumference from baseline to the end of study period.	3 months

External Links

•   Webpage of other collaborators
•   Webpage of the research group and contact info.