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

Metabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444558
• Other study ID #: Natural Supplement
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: October 2018
• Source: University of Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Natural 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.

Other:
• Placebo (without any active ingredients)
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.

Locations

Country	Name	City	State
Italy	University Hospital of Palermo	Palermo	Palrmo

Sponsors (2)

Lead Sponsor	Collaborator
University of Palermo	University of Catania

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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