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

NCT03444558 | Completed

• 1 other identifier: Natural Supplement
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

metabolic parameters; cardio-metabolic parameters

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (4)

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

  Change from baseline to 6 months of the supplementation

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

  Change from baseline to 6 months of the supplementation

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

  Change from baseline to 6 months of the supplementation

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

  Change from baseline to 6 months of the supplementation

Study Arms (2)

Dietary Supplement

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

50 subjects with the metabolic syndrome receiving placebo (without any active ingredients)

Other: Placebo (without any active ingredients)

Interventions

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.

Dietary Supplement

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Palermo: lead
• University of Catania: collaborator

Study Sites (1)

University Hospital of Palermo

Palermo, Palrmo, 90127, Italy

Location

Related 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.

  PMID: 19805654 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Luteolin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Manfredi Rizzo, MD, PhD

  University Hospital of Palermo, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Model Details: placebo-controlled study

Study Record Dates

• First Submitted: June 5, 2017
• First Posted: February 23, 2018
• Study Start: June 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: October 24, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)