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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2023-12-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Overweight and Obesity Hypercholesterolemia Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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INTERVENTION

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

Group Type EXPERIMENTAL

Silibinin A

Intervention Type DIETARY_SUPPLEMENT

The compound will be administered following a 300 mg / 3 day schedule, before each main meal.

CONTROL

Similar treatment regimen, but with a placebo.

Group Type PLACEBO_COMPARATOR

Silibinin A

Intervention Type DIETARY_SUPPLEMENT

The compound will be administered following a 300 mg / 3 day schedule, before each main meal.

Interventions

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Silibinin A

The compound will be administered following a 300 mg / 3 day schedule, before each main meal.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Milk thistle derivative

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes