Clinical trial NCT04698447: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Healthy Volunteers
Keywords: cardiovascular risk
extracellular vesicles
metabolic parameters
nutraceuticals
Citrus limon (L.)
Lead sponsor: University of Palermo
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: placebo-controlled study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change from Baseline in Plasma Lipids in Healthy Subjects
timeFrame: 3 months
measure: Change from Baseline in Plasma Lipids in Subjects with Metabolic Syndrome
timeFrame: 6 months
Secondary outcomes:
measure: Change from Baseline in Waist Circumference in Healthy Subjects
timeFrame: 3 months
measure: Change from Baseline in Waist Circumference in Subjects with Metabolic Syndrome
timeFrame: 6 months
measure: Change from Baseline in Body Mass Index (BMI) in Healthy Subjects
timeFrame: 3 months
measure: Change from Baseline in Body Mass Index (BMI) in Subjects with Metabolic Syndrome
timeFrame: 6 months
measure: Change from Baseline in Glycemia in Healthy Subjects
timeFrame: 3 months
measure: Change from Baseline in Glycemia in Subjects with Metabolic Syndrome
timeFrame: 6 months
measure: Change from Baseline in Glycated Haemoglobin in Healthy Subjects
timeFrame: 3 months
measure: Change from Baseline in Glycated Haemoglobin in Subjects with Metabolic Syndrome
timeFrame: 6 months
measure: Change from Baseline in Subclinical Atherosclerosis in Subjects with Metabolic Syndrome
timeFrame: 6 months
measure: Change from Baseline in Plasma Cytokines in Subjects with Metabolic Syndrome
timeFrame: 6 months
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: University Hospital of Palermo
Study officials:
affiliation: University Hospital of Palermo, Palermo, Italy
name: Giuseppe Montalto, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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