Metabolic Syndrome
Conditions
Keywords
metabolic parameters, cardio-metabolic parameters
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 health.
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%) 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).
Interventions
DIETARY_SUPPLEMENTNatural supplement containing chlorogenic acid and luteolin
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.
Sponsors
University of Catania
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blind study
Intervention model description
placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of natural supplement on metabolic parameters including plasma insulinemia and HOMA (homeostatic model assessment) index | Change from baseline to 6 months of the supplementation | 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. |
| Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI) | Change from baseline to 6 months of the supplementation | 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. |
| Effect of natural supplement on metabolic parameters including waist circumference | Change from baseline to 6 months of the supplementation | Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including waist circumference (cm). |
| Effect of natural supplement on metabolic parameters including plasma lipids | Change from baseline to 6 months of the supplementation | 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. |
| Effect of natural supplement on metabolic parameters including glucose metabolism parameters | Change from baseline to 6 months of the supplementation | Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma glycemia (mmol/l). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of natural supplement on cardio-metabolic parameters including plasma lipoproteins | Change from baseline to 6 months of the supplementation | 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. |
| Effect of natural supplement on cardio-metabolic parameters including subclinical atherosclerosis | Change from baseline to 6 months of the supplementation | Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including subclinical atherosclerosis assessed by carotid intima-media thickness (CIMT) (mm). |
| Effect of natural supplement on cardio-metabolic parameters including fatty liver index | Change from baseline to 6 months of the supplementation | 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. |
| Effect of natural supplement on cardio-metabolic parameters including plasma cytokines | Change from baseline to 6 months of the supplementation | 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. |
Countries
Italy
Outcome results
None listed