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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-02-28

Brief Summary

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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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Detailed Description

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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).

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

placebo-controlled study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

double-blind study

Study Groups

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Dietary Supplement

50 subjects with the metabolic syndrome receiving natural supplement containing chlorogenic acid and luteolin (450 mg/die)

Group Type EXPERIMENTAL

Natural supplement containing chlorogenic acid and luteolin

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo (without any active ingredients)

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No