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

Universidad Católica San Antonio de Murcia

Status: Active, not recruiting

Conditions: Hypertriglyceridemia; Hypercholesterolemia; Overweight and Obesity

Treatments: Dietary Supplement: Silibinin A

Study type: Interventional

Funder types: Other

Identifiers

NCT05069298

BIO-HPC_1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

INTERVENTION

Experimental group

Description:

Silibinin (A) for three months, with an administration regimen of 3 oral doses of 300 mg per day, before each main meal.

Treatment:

Dietary Supplement: Silibinin A

CONTROL

Placebo Comparator group

Description:

Similar treatment regimen, but with a placebo.

Treatment:

Dietary Supplement: Silibinin A