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

NCT ID: NCT04698447

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-28
• Study Completion Date: 2021-02-28

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.

Conditions

Metabolic Syndrome; Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Dietary Supplement blinded

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

Group Type: EXPERIMENTAL

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Placebo blinded

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

Group Type: PLACEBO_COMPARATOR

Placebo (without any active ingredients)

Intervention Type: DIETARY_SUPPLEMENT

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 Supplement open-label

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Natural 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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo (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.

Intervention Type: DIETARY_SUPPLEMENT

Natural 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.

Intervention Type: DIETARY_SUPPLEMENT

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;

Exclusion Criteria

• pregnancy or the willingness to become pregnant;
• severe renal or hepatic impairment;
• known severe infections (such as HIV, HBV, HCV)
• any neoplasms;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Montalto

MD, Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe Montalto, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Palermo, Palermo, Italy

Locations

University Hospital of Palermo

Palermo, , Italy

Countries

Italy

References

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Other Identifiers

Natural Supplement CitraVes

Identifier Type: -

Identifier Source: org_study_id