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

Primary Purpose

Metabolic Syndrome, Healthy Volunteers

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS
Placebo (without any active ingredients)
Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS
Sponsored by
University of Palermo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metabolic Syndrome focused on measuring cardiovascular risk, extracellular vesicles, metabolic parameters, nutraceuticals, Citrus limon (L.)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Hospital of Palermo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Dietary Supplement blinded

Placebo blinded

Dietary Supplement open-label

Arm Description

20 subjects with the metabolic syndrome receiving natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (1000 mg/day)

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

20 healthy volunteers receiving natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (1000 mg/day)

Outcomes

Primary Outcome Measures

Change from Baseline in Plasma Lipids in Healthy Subjects
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).
Change from Baseline in Plasma Lipids in Subjects with Metabolic Syndrome
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).

Secondary Outcome Measures

Change from Baseline in Waist Circumference in Healthy Subjects
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm).
Change from Baseline in Waist Circumference in Subjects with Metabolic Syndrome
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm).
Change from Baseline in Body Mass Index (BMI) in Healthy Subjects
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.
Change from Baseline in Body Mass Index (BMI) in Subjects with Metabolic Syndrome
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.
Change from Baseline in Glycemia in Healthy Subjects
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma glycemia (mmol/l).
Change from Baseline in Glycemia in Subjects with Metabolic Syndrome
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma glycemia (mmol/l).
Change from Baseline in Glycated Haemoglobin in Healthy Subjects
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on glycated haemoglobin (HbA1c) (%).
Change from Baseline in Glycated Haemoglobin in Subjects with Metabolic Syndrome
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on glycated haemoglobin (HbA1c) (%).
Change from Baseline in Subclinical Atherosclerosis in Subjects with Metabolic Syndrome
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on subclinical atherosclerosis assessed by carotid intima-media thickness (CIMT) (mm).
Change from Baseline in Plasma Cytokines in Subjects with Metabolic Syndrome
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.

Full Information

First Posted
December 27, 2020
Last Updated
January 5, 2021
Sponsor
University of Palermo
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1. Study Identification

Unique Protocol Identification Number
NCT04698447
Brief Title
The Role of a Natural Product, Containing Nanovesicles From Citrus Limon (L.) Juice, on Different CV Risk Factors
Official Title
Effects of the Natural Supplement CitraVes Containing Nanovesicles Delivered From Citrus Limon (L.) Juice on Cardio-metabolic Risk Factors in Subjects With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
June 19, 2020 (Actual)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Palermo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Healthy Volunteers
Keywords
cardiovascular risk, extracellular vesicles, metabolic parameters, nutraceuticals, Citrus limon (L.)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
placebo-controlled study
Masking
ParticipantInvestigator
Masking Description
double-blind study
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary Supplement blinded
Arm Type
Experimental
Arm Description
20 subjects with the metabolic syndrome receiving natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (1000 mg/day)
Arm Title
Placebo blinded
Arm Type
Placebo Comparator
Arm Description
20 subjects with the metabolic syndrome receiving placebo (without any active ingredients)
Arm Title
Dietary Supplement open-label
Arm Type
Active Comparator
Arm Description
20 healthy volunteers receiving natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (1000 mg/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo (without any active ingredients)
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Plasma Lipids in Healthy Subjects
Description
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).
Time Frame
3 months
Title
Change from Baseline in Plasma Lipids in Subjects with Metabolic Syndrome
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Waist Circumference in Healthy Subjects
Description
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm).
Time Frame
3 months
Title
Change from Baseline in Waist Circumference in Subjects with Metabolic Syndrome
Description
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm).
Time Frame
6 months
Title
Change from Baseline in Body Mass Index (BMI) in Healthy Subjects
Description
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.
Time Frame
3 months
Title
Change from Baseline in Body Mass Index (BMI) in Subjects with Metabolic Syndrome
Description
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.
Time Frame
6 months
Title
Change from Baseline in Glycemia in Healthy Subjects
Description
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma glycemia (mmol/l).
Time Frame
3 months
Title
Change from Baseline in Glycemia in Subjects with Metabolic Syndrome
Description
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma glycemia (mmol/l).
Time Frame
6 months
Title
Change from Baseline in Glycated Haemoglobin in Healthy Subjects
Description
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on glycated haemoglobin (HbA1c) (%).
Time Frame
3 months
Title
Change from Baseline in Glycated Haemoglobin in Subjects with Metabolic Syndrome
Description
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on glycated haemoglobin (HbA1c) (%).
Time Frame
6 months
Title
Change from Baseline in Subclinical Atherosclerosis in Subjects with Metabolic Syndrome
Description
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on subclinical atherosclerosis assessed by carotid intima-media thickness (CIMT) (mm).
Time Frame
6 months
Title
Change from Baseline in Plasma Cytokines in Subjects with Metabolic Syndrome
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Montalto, MD
Organizational Affiliation
University Hospital of Palermo, Palermo, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Palermo
City
Palermo
ZIP/Postal Code
90127
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27076875
Citation
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Corrado C, Raimondo S, Chiesi A, Ciccia F, De Leo G, Alessandro R. Exosomes as intercellular signaling organelles involved in health and disease: basic science and clinical applications. Int J Mol Sci. 2013 Mar 6;14(3):5338-66. doi: 10.3390/ijms14035338.
Results Reference
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Lakkaraju A, Rodriguez-Boulan E. Itinerant exosomes: emerging roles in cell and tissue polarity. Trends Cell Biol. 2008 May;18(5):199-209. doi: 10.1016/j.tcb.2008.03.002. Epub 2008 Apr 7.
Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
Raimondo S, Naselli F, Fontana S, Monteleone F, Lo Dico A, Saieva L, Zito G, Flugy A, Manno M, Di Bella MA, De Leo G, Alessandro R. Citrus limon-derived nanovesicles inhibit cancer cell proliferation and suppress CML xenograft growth by inducing TRAIL-mediated cell death. Oncotarget. 2015 Aug 14;6(23):19514-27. doi: 10.18632/oncotarget.4004.
Results Reference
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The Role of a Natural Product, Containing Nanovesicles From Citrus Limon (L.) Juice, on Different CV Risk Factors

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