Status:
COMPLETED
Effects of Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors
Lead Sponsor:
University of Palermo
Collaborating Sponsors:
University of Catania
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Clinical trial about beneficial effects of natural ingredient containing chlorogenic acid and luteolin on liver health and conditions related to liver (such as metabolic syndrome) for general body hea...
Detailed Description
This is one randomized, double-blind, placebo-controlled study. The purpose of the present study is to evaluate and/or elucidate the role of the natural supplement, containing chlorogenic acid (10-12%...
Eligibility Criteria
Inclusion
- Men and women aged \>18 years with the metabolic syndrome (as defined by the international criteria: Alberti KG, et al. Circulation. 2009; 120: 1640-5);
- BMI\> 25 kg/m\^2;
- Subjects able to swallow whole tablets;
- Informed consent obtained prior to any study-related activities.
Exclusion
- Pregnancy or willingness to become pregnant;
- Severe liver dysfunction (ALT \>2.5 times upper limit of normal);
- Severe renal failure (eGFR\<60 mL/min/1.73 m2 using the MDRD formula);
- Severe infections at the discretion of the investigator (such as HIV, HBV and HCV);
- History or presence of malignant neoplasms within the last 5 years.
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03444558
Start Date
June 1 2017
End Date
February 28 2018
Last Update
October 24 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital of Palermo
Palermo, Palrmo, Italy, 90127