Effects of Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors

Effect of a Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome

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 health.

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%) and luteinyl-7-glucoside (2-4%), on cardio-metabolic risk factors.

The research hypothesis is to evaluate whether natural supplement containing chlorogenic acid and luteolin (Puraltilix, BIONAP SRL, Catania, Italy) may improve several cardio-metabolic parameters in subjects with the metabolic syndrome.

All subjects will be evaluated at baseline and after 6 months of treatment (with natural supplement or placebo).

Inclusion Criteria:

• 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 Criteria:

• 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.