The Role of a Natural Product, Containing Nanovesicles From Citrus Limon (L.) Juice, on Different CV Risk Factors

January 5, 2021 updated by: Giuseppe Montalto, University of Palermo

Effects of the Natural Supplement CitraVes Containing Nanovesicles Delivered From Citrus Limon (L.) Juice on Cardio-metabolic Risk Factors in Subjects With Metabolic Syndrome

Clinical trial about beneficial effects of natural supplement in a spray-dried formulation, citraVes™, obtained from Citrus Limon (L.) juice on general body health.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is one randomized, double-blind, placebo-controlled study. The aim of the present study is to investigate the role of a natural product, citraVes™ on several cardiovascular risk factors.

The research hypothesis is to evaluate whether this natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (Navhetec S.R.L., Palermo, Italy) may improve different cardio-metabolic parameters in subjects with the metabolic syndrome. All subjects will be evaluated at baseline, after 1 month and after 3 and 6 months of supplementation with natural product or placebo.

Study Type

Interventional

Enrollment (Actual)

60

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
      • Palermo, 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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men and women > 18 years old;
  • body mass index (BMI) > 25 kg/m²;
  • subjects who are able to swallow;
  • subjects who are willing to participate in the study and therefore, to sign informed consent prior to any study procedure;
  • the inclusion criteria for patients with MetS was also the diagnosis of MetS, as defined by international consensus [Alberti KG, et al. Circulation. 2009; 120:1640-5].

Exclusion Criteria:

  • pregnancy or the willingness to become pregnant;
  • severe renal or hepatic impairment;
  • known severe infections (such as HIV, HBV, HCV)
  • any neoplasms;
  • the exclusion criteria for healthy volunteers were also diagnosis of any one of the following diseases: hypertension, diabetes mellitus, dyslipidaemia or metabolic diseases.

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 blinded
20 subjects with the metabolic syndrome receiving natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (1000 mg/day)
Dietary supplement: Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS
20 eligible subjects with the metabolic syndrome (MetS) will take natural supplement containing a spray-dried formulation of citraVes™, directly in the mouth, without water, to be dissolved preferably under the tongue, at a stable dose of one sachet a day (1000 mg/day) for 6 months and as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.
Placebo Comparator: Placebo blinded
20 subjects with the metabolic syndrome receiving placebo (without any active ingredients)
Dietary supplement: Placebo (without any active ingredients)
20 eligible subjects with the metabolic syndrome will take placebo in a spray-dried formulation (without any active ingredients) directly in the mouth, without water, to be dissolved preferably under the tongue, at a stable dose of one sachet a day for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.
Active Comparator: Dietary Supplement open-label
20 healthy volunteers receiving natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (1000 mg/day)
Dietary supplement: Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS
20 eligible healthy subjects (HS) will take natural supplement containing a spray-dried formulation of citraVes™, directly in the mouth, without water, to be dissolved preferably under the tongue, at a stable dose of one sachet a day (1000 mg/day) for 6 months, maintained at fixed doses for the entire study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Plasma Lipids in Healthy Subjects
Time Frame: 3 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on low-density lipoprotein cholesterol (LDL-C), total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-C) (mmol/l).
3 months
Change from Baseline in Plasma Lipids in Subjects with Metabolic Syndrome
Time Frame: 6 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on low-density lipoprotein cholesterol (LDL-C), total cholesterol, triglycerides, and high-density lipoprotein cholesterol (HDL-C) (mmol/l).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Waist Circumference in Healthy Subjects
Time Frame: 3 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm).
3 months
Change from Baseline in Waist Circumference in Subjects with Metabolic Syndrome
Time Frame: 6 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm).
6 months
Change from Baseline in Body Mass Index (BMI) in Healthy Subjects
Time Frame: 3 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on body weight (kg) and height (m) that will be combined to report BMI in kg/m^2.
3 months
Change from Baseline in Body Mass Index (BMI) in Subjects with Metabolic Syndrome
Time Frame: 6 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on body weight (kg) and height (m) that will be combined to report BMI in kg/m^2.
6 months
Change from Baseline in Glycemia in Healthy Subjects
Time Frame: 3 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma glycemia (mmol/l).
3 months
Change from Baseline in Glycemia in Subjects with Metabolic Syndrome
Time Frame: 6 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma glycemia (mmol/l).
6 months
Change from Baseline in Glycated Haemoglobin in Healthy Subjects
Time Frame: 3 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on glycated haemoglobin (HbA1c) (%).
3 months
Change from Baseline in Glycated Haemoglobin in Subjects with Metabolic Syndrome
Time Frame: 6 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on glycated haemoglobin (HbA1c) (%).
6 months
Change from Baseline in Subclinical Atherosclerosis in Subjects with Metabolic Syndrome
Time Frame: 6 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on subclinical atherosclerosis assessed by carotid intima-media thickness (CIMT) (mm).
6 months
Change from Baseline in Plasma Cytokines in Subjects with Metabolic Syndrome
Time Frame: 6 months
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma cytokines (inflammatory markers) (pg/ml), that will be assessed using available enzyme-linked immunosorbent assay (ELISA) kits.
6 months

Collaborators and Investigators

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

Sponsor

University of Palermo

Investigators

  • Principal Investigator: Giuseppe Montalto, MD, University Hospital of Palermo, 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)

March 28, 2019

Primary Completion (Actual)

June 19, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

December 27, 2020

First Submitted That Met QC Criteria

January 5, 2021

First Posted (Actual)

January 6, 2021

Study Record Updates

Last Update Posted (Actual)

January 6, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Natural Supplement CitraVes

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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