Clinical trial about beneficial effects of natural supplement in a spray-dried formulation, citraVes™, obtained from Citrus Limon (L.) juice on general body health.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
60
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.
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.
University Hospital of Palermo
Palermo, Italy
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).
Time frame: 3 months
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).
Time frame: 6 months
Change from Baseline in Waist Circumference in Healthy Subjects
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm).
Time frame: 3 months
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).
Time frame: 6 months
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.
Time frame: 3 months
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.
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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.
Time frame: 6 months
Change from Baseline in Glycemia in Healthy Subjects
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma glycemia (mmol/l).
Time frame: 3 months
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).
Time frame: 6 months
Change from Baseline in Glycated Haemoglobin in Healthy Subjects
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on glycated haemoglobin (HbA1c) (%).
Time frame: 3 months
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) (%).
Time frame: 6 months
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).
Time frame: 6 months
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.
Time frame: 6 months