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NCT Number: NCT03444558

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

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Palermo

Palermo, Palrmo, 90127, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natural supplement containing chlorogenic acid and luteolin

Dietary Supplement

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.

Placebo (without any active ingredients)

Other

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.

Primary outcomes

  1. Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI)

    Time frame: 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.

  2. Effect of natural supplement on metabolic parameters including waist circumference

    Time frame: 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).

  3. Effect of natural supplement on metabolic parameters including plasma lipids

    Time frame: 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.

  4. Effect of natural supplement on metabolic parameters including glucose metabolism parameters

    Time frame: 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).

  5. Effect of natural supplement on metabolic parameters including plasma insulinemia and HOMA (homeostatic model assessment) index

    Time frame: 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.

Secondary outcomes

  1. Effect of natural supplement on cardio-metabolic parameters including plasma cytokines

    Time frame: 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.

  2. Effect of natural supplement on cardio-metabolic parameters including plasma lipoproteins

    Time frame: 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.

  3. Effect of natural supplement on cardio-metabolic parameters including subclinical atherosclerosis

    Time frame: 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).

  4. Effect of natural supplement on cardio-metabolic parameters including fatty liver index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Palermo

Other

Collaborators

  • University of Catania

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2018
Registry last updated
Oct 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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