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

Not Applicable

• Conditions: Healthy Volunteers; Metabolic Syndrome
• Interventions: Dietary Supplement: Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS; Dietary Supplement: Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS; Dietary Supplement: Placebo (without any active ingredients)

• Registration Number: NCT04698447
• Lead Sponsor: University of Palermo

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.

Study Timeline

• Study Start: 2019-03-28
• Primary Completion: 2020-06-19
• Study First Submitted: 2020-12-27
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-05
• Last Update Submitted: 2021-01-05
• Study First Posted: 2021-01-06
• Last Update Posted: 2021-01-06
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dietary Supplement open-label	Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS	20 healthy volunteers receiving natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (1000 mg/day)
Dietary Supplement blinded	Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS	20 subjects with the metabolic syndrome receiving natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (1000 mg/day)
Placebo blinded	Placebo (without any active ingredients)	20 subjects with the metabolic syndrome receiving placebo (without any active ingredients)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Glycemia in Subjects with Metabolic Syndrome	6 months	Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma glycemia (mmol/l).
Change from Baseline in Waist Circumference in Healthy Subjects	3 months	Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm).
Change from Baseline in Glycemia in Healthy Subjects	3 months	Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma glycemia (mmol/l).
Change from Baseline in Waist Circumference in Subjects with Metabolic Syndrome	6 months	Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm).
Change from Baseline in Glycated Haemoglobin in Subjects with Metabolic Syndrome	6 months	Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on glycated haemoglobin (HbA1c) (%).
Change from Baseline in Plasma Cytokines in Subjects with Metabolic Syndrome	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.
Change from Baseline in Body Mass Index (BMI) in Healthy Subjects	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.
Change from Baseline in Body Mass Index (BMI) in Subjects with Metabolic Syndrome	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.
Change from Baseline in Glycated Haemoglobin in Healthy Subjects	3 months	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	6 months	Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on subclinical atherosclerosis assessed by carotid intima-media thickness (CIMT) (mm).

Trial Locations

Locations (1)

University Hospital of Palermo; 🇮🇹 Palermo, Italy