Clinical trial NCT03444558: Effects of Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors
Official title: Effect of a Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic parameters
cardio-metabolic parameters
Lead sponsor: University of Palermo
Sponsor class: OTHER
Collaborators: name: University of Catania
First posted: 2018-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo-controlled study
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI)
timeFrame: Change from baseline to 6 months of the supplementation
measure: Effect of natural supplement on metabolic parameters including waist circumference
timeFrame: Change from baseline to 6 months of the supplementation
measure: Effect of natural supplement on metabolic parameters including plasma lipids
timeFrame: Change from baseline to 6 months of the supplementation
measure: Effect of natural supplement on metabolic parameters including glucose metabolism parameters
timeFrame: Change from baseline to 6 months of the supplementation
measure: Effect of natural supplement on metabolic parameters including plasma insulinemia and HOMA (homeostatic model assessment) index
timeFrame: Change from baseline to 6 months of the supplementation
Secondary outcomes:
measure: Effect of natural supplement on cardio-metabolic parameters including plasma cytokines
timeFrame: Change from baseline to 6 months of the supplementation
measure: Effect of natural supplement on cardio-metabolic parameters including plasma lipoproteins
timeFrame: Change from baseline to 6 months of the supplementation
measure: Effect of natural supplement on cardio-metabolic parameters including subclinical atherosclerosis
timeFrame: Change from baseline to 6 months of the supplementation
measure: Effect of natural supplement on cardio-metabolic parameters including fatty liver index
timeFrame: Change from baseline to 6 months of the supplementation
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: University Hospital of Palermo
state: Palrmo
Study officials:
affiliation: University Hospital of Palermo, Italy
name: Manfredi Rizzo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.