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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Natural supplement containing chlorogenic acid and luteolin
* Other: Placebo (without any active ingredients)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: placebo-controlled study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dietary Supplement<br>50 subjects with the metabolic syndrome receiving natural supplement containing chlorogenic acid and luteolin (450 mg/die) | Dietary Supplement: Natural supplement containing chlorogenic acid and luteolin<br>* 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.<br>|
| Placebo Comparator: Placebo<br>50 subjects with the metabolic syndrome receiving placebo (without any active ingredients) | Other: Placebo (without any active ingredients)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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). | 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. | Change from baseline to 6 months of the supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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. | Change from baseline to 6 months of the supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic parameters, cardio-metabolic parameters