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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Overweight and Obesity, Hypercholesterolemia, Hypertriglyceridemia

Intervention / Treatment
-----------------
* Dietary Supplement: Silibinin A


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INTERVENTION<br>Silibinin (A) for three months, with an administration regimen of 3 oral doses of 300 mg per day, before each main meal. | Dietary Supplement: Silibinin A<br>* The compound will be administered following a 300 mg / 3 day schedule, before each main meal.<br>* Other names: Milk thistle derivative;|
| Placebo Comparator: CONTROL<br>Similar treatment regimen, but with a placebo. | Dietary Supplement: Silibinin A<br>* The compound will be administered following a 300 mg / 3 day schedule, before each main meal.<br>* Other names: Milk thistle derivative;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of total body weight loss | Change in body weight from baseline to the end of study period (3 months). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma total cholesterol | Change in plasma total cholesterol levels from baseline to the end of study period (3 months). | 3 months | 
| Plasma low density level cholesterol (cLDL) | Change in plasma cLDL levels from baseline to the end of study period (3 months). | 3 months | 
| Plasma triglycerides | Change in plasma triglyceride levels from baseline to the end of study period (3 months). | 3 months | 
| Body mass index (BMI) | Change in BMI from baseline to the end of study period. | 3 months | 
| Body fat percentage | Change in body fat from baseline to the end of study period. | 3 months | 
| Waist circumference | Change in waist circumference from baseline to the end of study period. | 3 months |