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

October 23, 2018 updated by: Manfredi Rizzo, University of Palermo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Palrmo
      • Palermo, Palrmo, Italy, 90127
        • University Hospital of Palermo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dietary Supplement
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
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 Comparator: Placebo
50 subjects with the metabolic syndrome receiving placebo (without any active ingredients)
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Palermo

Collaborators

University of Catania

Investigators

  • Principal Investigator: Manfredi Rizzo, MD, PhD, University Hospital of Palermo, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

June 5, 2017

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

October 24, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Natural Supplement

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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