Status:
UNKNOWN
The Role of a Natural Product, Containing Nanovesicles From Citrus Limon (L.) Juice, on Different CV Risk Factors
Lead Sponsor:
University of Palermo
Conditions:
Metabolic Syndrome
Healthy Volunteers
Eligibility:
All Genders
18+ years
Phase:
NA
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 res...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04698447
Start Date
March 28 2019
End Date
February 1 2021
Last Update
January 6 2021
Active Locations (1)
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1
University Hospital of Palermo
Palermo, Italy, 90127