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

Not Applicable

Active, not recruiting

• Conditions: Hypertriglyceridemia; Hypercholesterolemia; Overweight and Obesity
• Interventions: Dietary Supplement: Silibinin A

• Registration Number: NCT05069298
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-29
• Study First Submitted QC: 2021-10-05
• Study First Posted: 2021-10-06
• Study Start: 2023-01-12
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-22
• Last Update Posted: 2023-06-23
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTERVENTION	Silibinin A	Silibinin (A) for three months, with an administration regimen of 3 oral doses of 300 mg per day, before each main meal.
CONTROL	Silibinin A	Similar treatment regimen, but with a placebo.

Primary Outcome Measures

Name	Time	Method
Percentage of total body weight loss	3 months	Change in body weight from baseline to the end of study period (3 months).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Nursing. Catholic University of Murcia; 🇪🇸 Murcia, Spain