NCT03444558

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Palermo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-02-28
• Completion: 2018-02-28
• First posted: 2018-02-23
• Last updated: 2018-10-24

Locations

1 site across 1 country: Italy