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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypercholesterolemia; Overweight and Obesity; Hypertriglyceridemia
• Intervention / Treatment: Dietary supplement: Silibinin A

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain, 30107
    • Faculty of Nursing. Catholic University of Murcia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INTERVENTION; 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; The compound will be administered following a 300 mg / 3 day schedule, before each main meal.; Other Names: Milk thistle derivative
Placebo Comparator: CONTROL; Similar treatment regimen, but with a placebo.	Dietary supplement: Silibinin A; The compound will be administered following a 300 mg / 3 day schedule, before each main meal.; 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

Collaborators and Investigators

• Sponsor: Universidad Católica San Antonio de Murcia
• Investigators: Principal Investigator: Juan José Hernández Morante, PhD, Catholic University of Murcia

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 21, 2023

Study Registration Dates

• First Submitted: May 29, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Obesity; Overweight; Hypercholesterolemia; Hypertriglyceridemia; Physiological Effects of Drugs; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Silybin
• Other Study ID Numbers: BIO-HPC_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data derived from the present trial will be located in public domain databases, concretely in the Mendeley data repository (https://data.mendeley.com/). Nevertheless, all data will be available by request to the main researcher, Dr. Juan José Hernández Morante (e-mail:jjhernandez@ucam.edu).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No