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

NCT04698447 | Unknown

• 1 other identifier: Natural Supplement CitraVes
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome; Healthy Volunteers

Keywords

cardiovascular risk; extracellular vesicles; metabolic parameters; nutraceuticals; Citrus limon (L.)

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  6 months

Secondary Outcomes (10)

• Change from Baseline in Waist Circumference in Healthy Subjects

  3 months

• Change from Baseline in Waist Circumference in Subjects with Metabolic Syndrome

  6 months

• Change from Baseline in Body Mass Index (BMI) in Healthy Subjects

  3 months

• Change from Baseline in Body Mass Index (BMI) in Subjects with Metabolic Syndrome

  6 months

• Change from Baseline in Glycemia in Healthy Subjects

  3 months

Study Arms (3)

Dietary Supplement blinded

EXPERIMENTAL

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

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

Placebo blinded

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo (without any active ingredients)

Dietary Supplement open-label

ACTIVE COMPARATOR

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

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

Interventions

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

Dietary Supplement blinded

Placebo (without any active ingredients) 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.

Placebo blinded

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

Dietary Supplement open-label

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• University of Palermo: lead

Study Sites (1)

University Hospital of Palermo

Palermo, 90127, Italy

Location

Related Publications (7)

• Martinez-Abundis E, Mendez-Del Villar M, Perez-Rubio KG, Zuniga LY, Cortez-Navarrete M, Ramirez-Rodriguez A, Gonzalez-Ortiz M. Novel nutraceutic therapies for the treatment of metabolic syndrome. World J Diabetes. 2016 Apr 10;7(7):142-52. doi: 10.4239/wjd.v7.i7.142.

  PMID: 27076875 BACKGROUND

• Corrado C, Raimondo S, Chiesi A, Ciccia F, De Leo G, Alessandro R. Exosomes as intercellular signaling organelles involved in health and disease: basic science and clinical applications. Int J Mol Sci. 2013 Mar 6;14(3):5338-66. doi: 10.3390/ijms14035338.

  PMID: 23466882 BACKGROUND

• Lakkaraju A, Rodriguez-Boulan E. Itinerant exosomes: emerging roles in cell and tissue polarity. Trends Cell Biol. 2008 May;18(5):199-209. doi: 10.1016/j.tcb.2008.03.002. Epub 2008 Apr 7.

  PMID: 18396047 BACKGROUND

• Wang B, Zhuang X, Deng ZB, Jiang H, Mu J, Wang Q, Xiang X, Guo H, Zhang L, Dryden G, Yan J, Miller D, Zhang HG. Targeted drug delivery to intestinal macrophages by bioactive nanovesicles released from grapefruit. Mol Ther. 2014 Mar;22(3):522-534. doi: 10.1038/mt.2013.190. Epub 2013 Aug 13.

  PMID: 23939022 BACKGROUND

• Ju S, Mu J, Dokland T, Zhuang X, Wang Q, Jiang H, Xiang X, Deng ZB, Wang B, Zhang L, Roth M, Welti R, Mobley J, Jun Y, Miller D, Zhang HG. Grape exosome-like nanoparticles induce intestinal stem cells and protect mice from DSS-induced colitis. Mol Ther. 2013 Jul;21(7):1345-57. doi: 10.1038/mt.2013.64. Epub 2013 Jun 11.

  PMID: 23752315 BACKGROUND

• Raimondo S, Naselli F, Fontana S, Monteleone F, Lo Dico A, Saieva L, Zito G, Flugy A, Manno M, Di Bella MA, De Leo G, Alessandro R. Citrus limon-derived nanovesicles inhibit cancer cell proliferation and suppress CML xenograft growth by inducing TRAIL-mediated cell death. Oncotarget. 2015 Aug 14;6(23):19514-27. doi: 10.18632/oncotarget.4004.

  PMID: 26098775 BACKGROUND

• Li C, Schluesener H. Health-promoting effects of the citrus flavanone hesperidin. Crit Rev Food Sci Nutr. 2017 Feb 11;57(3):613-631. doi: 10.1080/10408398.2014.906382.

  PMID: 25675136 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Giuseppe Montalto, MD

  University Hospital of Palermo, Palermo, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double-blind study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Full Professor

Model Details: placebo-controlled study

Study Record Dates

• First Submitted: December 27, 2020
• First Posted: January 6, 2021
• Study Start: March 28, 2019
• Primary Completion: June 19, 2020
• Study Completion: February 1, 2021
• Last Updated: January 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)