Healthy Volunteers, Metabolic Syndrome
Conditions
Keywords
cardiovascular risk, extracellular vesicles, metabolic parameters, nutraceuticals, Citrus limon (L.)
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.
Interventions
DIETARY_SUPPLEMENTNatural 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.
DIETARY_SUPPLEMENTPlacebo (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.
DIETARY_SUPPLEMENTNatural 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.
Sponsors
University of Palermo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blind study
Intervention model description
placebo-controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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). |
| 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 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 Waist Circumference in Subjects with Metabolic Syndrome | 6 months | Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm). |
Countries
Italy
Outcome results
None listed