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

University of Palermo

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Other: Placebo (without any active ingredients)

Dietary Supplement: Natural supplement containing chlorogenic acid and luteolin

Study type

Interventional

Funder types

Other

Identifiers

NCT03444558

Natural Supplement

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.