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

University of Palermo

Status: Unknown

Conditions: Healthy Volunteers; Metabolic Syndrome

Treatments: Dietary Supplement: Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS; Dietary Supplement: Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS; Dietary Supplement: Placebo (without any active ingredients)

Study type: Interventional

Funder types: Other

Identifiers

NCT04698447

Natural Supplement CitraVes

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Dietary Supplement blinded

Experimental group

Description:

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

Treatment:

Dietary Supplement: Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS

Placebo blinded

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo (without any active ingredients)

Dietary Supplement open-label

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS