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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05069298
Other study ID # BIO-HPC_1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 12, 2023
Est. completion date December 21, 2023

Study information

Verified date June 2023
Source Universidad Católica San Antonio de Murcia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date December 21, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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


Intervention

Dietary Supplement:
Silibinin A
The compound will be administered following a 300 mg / 3 day schedule, before each main meal.

Locations

Country Name City State
Spain Faculty of Nursing. Catholic University of Murcia Murcia

Sponsors (1)

Lead Sponsor Collaborator
Universidad Católica San Antonio de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of total body weight loss Change in body weight from baseline to the end of study period (3 months). 3 months
Secondary Plasma total cholesterol Change in plasma total cholesterol levels from baseline to the end of study period (3 months). 3 months
Secondary Plasma low density level cholesterol (cLDL) Change in plasma cLDL levels from baseline to the end of study period (3 months). 3 months
Secondary Plasma triglycerides Change in plasma triglyceride levels from baseline to the end of study period (3 months). 3 months
Secondary Body mass index (BMI) Change in BMI from baseline to the end of study period. 3 months
Secondary Body fat percentage Change in body fat from baseline to the end of study period. 3 months
Secondary Waist circumference Change in waist circumference from baseline to the end of study period. 3 months
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