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

Primary Purpose

Overweight and Obesity, Hypercholesterolemia, Hypertriglyceridemia

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Silibinin A
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Faculty of Nursing. Catholic University of Murcia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

INTERVENTION

CONTROL

Arm Description

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

Similar treatment regimen, but with a placebo.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2021
Last Updated
June 22, 2023
Sponsor
Universidad Católica San Antonio de Murcia
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1. Study Identification

Unique Protocol Identification Number
NCT05069298
Brief Title
Effect of Silibinin(A) as a Potential Anti-obesity Agent
Official Title
Effect of Milk Thistle Derivative Silibinin(A) as a Potential Anti-obesity Agent
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Hypercholesterolemia, Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INTERVENTION
Arm Type
Experimental
Arm Description
Silibinin (A) for three months, with an administration regimen of 3 oral doses of 300 mg per day, before each main meal.
Arm Title
CONTROL
Arm Type
Placebo Comparator
Arm Description
Similar treatment regimen, but with a placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Silibinin A
Other Intervention Name(s)
Milk thistle derivative
Intervention Description
The compound will be administered following a 300 mg / 3 day schedule, before each main meal.
Primary Outcome Measure Information:
Title
Percentage of total body weight loss
Description
Change in body weight from baseline to the end of study period (3 months).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Plasma total cholesterol
Description
Change in plasma total cholesterol levels from baseline to the end of study period (3 months).
Time Frame
3 months
Title
Plasma low density level cholesterol (cLDL)
Description
Change in plasma cLDL levels from baseline to the end of study period (3 months).
Time Frame
3 months
Title
Plasma triglycerides
Description
Change in plasma triglyceride levels from baseline to the end of study period (3 months).
Time Frame
3 months
Title
Body mass index (BMI)
Description
Change in BMI from baseline to the end of study period.
Time Frame
3 months
Title
Body fat percentage
Description
Change in body fat from baseline to the end of study period.
Time Frame
3 months
Title
Waist circumference
Description
Change in waist circumference from baseline to the end of study period.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan José Hernández Morante, PhD
Organizational Affiliation
Catholic University of Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Nursing. Catholic University of Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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).
Links:
URL
http://bio-hpc.ucam.edu/ucamhealth/
Description
Webpage of the research group and contact info.
URL
http://bio-hpc.ucam.edu/
Description
Webpage of other collaborators

Learn more about this trial

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

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