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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
100
50 eligible subjects will receive natural supplement as the oral pills at a fixed dose of 1 pill/day (450 mg/day) for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.
50 eligible subjects will receive placebo (without any active ingredients) at a fixed dose of 1 pill/day for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.
University Hospital of Palermo
Palermo, Palrmo, Italy
Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI)
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including body weight (kg) and height (m) that will be combined to report BMI in kg/m\^2.
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement on metabolic parameters including waist circumference
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including waist circumference (cm).
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement on metabolic parameters including plasma lipids
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol HDL-C) (mmol/l), while low-density lipoprotein cholesterol (LDL-C) will be calculated using the Friedewald formula.
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement on metabolic parameters including glucose metabolism parameters
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma glycemia (mmol/l).
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement on metabolic parameters including plasma insulinemia and HOMA (homeostatic model assessment) index
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma insulinemia (pmol/L) that with glycemia will be combined to report HOMA index.
Time frame: Change from baseline to 6 months of the supplementation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Effect of natural supplement on cardio-metabolic parameters including plasma cytokines
Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including plasma cytokines (inflammatory markers and adipokines) (pg/ml), that will be assessed using available enzyme-linked immunosorbent assay (ELISA) kits.
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement on cardio-metabolic parameters including plasma lipoproteins
Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including atherogenic lipoproteins as well as the analysis of the full spectrum of lipoprotein subclasses by gel electrophoresis.
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement on cardio-metabolic parameters including subclinical atherosclerosis
Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including subclinical atherosclerosis assessed by carotid intima-media thickness (CIMT) (mm).
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement on cardio-metabolic parameters including fatty liver index
Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including fatty liver index, a noninvasive method used for steatosis detection and quantification.
Time frame: Change from baseline to 6 months of the supplementation