Metabolic SyndromeNCT04698447
The Role of a Natural Product, Containing Nanovesicles From Citrus Limon (L.) Juice, on Different CV Risk Factors
A study testing Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS and Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS in people with Metabolic Syndrome and Healthy Volunteers, run by University of Palermo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Healthy Volunteers
- What is being tested?
- Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS and Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 28 Mar 2019to Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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].
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Natural Supplement CitraVes Containing Nanovesicles Delivered From Citrus Limon (L.) Juice on Cardio-metabolic Risk Factors in Subjects With Metabolic Syndrome
Clinical trial about beneficial effects of natural supplement in a spray-dried formulation, citraVes™, obtained from Citrus Limon (L.) juice on general body health.
Read the 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
- Being tested
- Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS, Placebo (without any active ingredients), Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS
- Keywords
- cardiovascular risk, extracellular vesicles, metabolic parameters, nutraceuticals, Citrus limon (L.)
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetSDietary 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 (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.
Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HSDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement blinded | Experimental | 20 subjects with the metabolic syndrome receiving natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (1000 mg/day) Receives: 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) Receives: 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) Receives: Dietary Supplement: Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 6 months
Secondary outcomes (10)
Change from Baseline in Waist Circumference in Healthy Subjects
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm).
Measured: 3 months
Change from Baseline in Waist Circumference in Subjects with Metabolic Syndrome
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on waist circumference (cm).
Measured: 6 months
Change from Baseline in Body Mass Index (BMI) in Healthy Subjects
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.
Measured: 3 months
Change from Baseline in Body Mass Index (BMI) in Subjects with Metabolic Syndrome
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.
Measured: 6 months
Change from Baseline in Glycemia in Healthy Subjects
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma glycemia (mmol/l).
Measured: 3 months
Change from Baseline in Glycemia in Subjects with Metabolic Syndrome
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on plasma glycemia (mmol/l).
Measured: 6 months
Change from Baseline in Glycated Haemoglobin in Healthy Subjects
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on glycated haemoglobin (HbA1c) (%).
Measured: 3 months
Change from Baseline in Glycated Haemoglobin in Subjects with Metabolic Syndrome
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on glycated haemoglobin (HbA1c) (%).
Measured: 6 months
Change from Baseline in Subclinical Atherosclerosis in Subjects with Metabolic Syndrome
Effect of natural supplement containing nanovesicles from Citrus Limon (L.) juice on subclinical atherosclerosis assessed by carotid intima-media thickness (CIMT) (mm).
Measured: 6 months
Change from Baseline in Plasma Cytokines in Subjects with Metabolic Syndrome
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start28 Mar 2019
- Primary completion19 Jun 2020
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Montalto, University of Palermo
- Investigators
- Giuseppe Montalto, MD, Principal investigator, University Hospital of Palermo, Palermo, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698447
- Sponsor's protocol ID
- Natural Supplement CitraVes
- Status last verified
- Jan 2021
- First submitted
- 27 Dec 2020
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27076875Corrado 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.
PubMed 23466882Lakkaraju 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.
PubMed 18396047Wang 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.
PubMed 23939022Ju 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.
PubMed 23752315Raimondo 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.
PubMed 26098775Li 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.
PubMed 25675136
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Natural Supplement CitraVes Containing Nanovesicles Delivered From Citrus Limon (L.) Juice on Cardio-metabolic Risk Factors in Subjects With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04698447
- Acronym / sponsor ID
- Natural Supplement CitraVes
- Conditions
- Metabolic Syndrome, Healthy Volunteers
- Keywords
- cardiovascular risk, extracellular vesicles, metabolic parameters, nutraceuticals, Citrus limon (L.)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 19 Jun 2020 (actual)
- Study completion
- Feb 2021 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement blinded | Experimental | Dietary Supplement: Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS20 subjects with the metabolic syndrome receiving natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (1000 mg/day) |
| Placebo blinded | Placebo comparator | Dietary Supplement: Placebo (without any active ingredients)20 subjects with the metabolic syndrome receiving placebo (without any active ingredients) |
| Dietary Supplement open-label | Active comparator | Dietary Supplement: Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS20 healthy volunteers receiving natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice (1000 mg/day) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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].
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS20 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 | Dietary Supplement blinded |
| 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. | Dietary supplement | Placebo blinded |
| Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS20 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 | Dietary Supplement open-label |
Primary outcome
Change from Baseline in Plasma Lipids in Healthy Subjects
Time frame: 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
Time frame: 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).
10 secondary outcomes
Change from Baseline in Waist Circumference in Healthy Subjects
Time frame: 3 months
Change from Baseline in Waist Circumference in Subjects with Metabolic Syndrome
Time frame: 6 months
Change from Baseline in Body Mass Index (BMI) in Healthy Subjects
Time frame: 3 months
Change from Baseline in Body Mass Index (BMI) in Subjects with Metabolic Syndrome
Time frame: 6 months
Change from Baseline in Glycemia in Healthy Subjects
Time frame: 3 months
Change from Baseline in Glycemia in Subjects with Metabolic Syndrome
Time frame: 6 months
Change from Baseline in Glycated Haemoglobin in Healthy Subjects
Time frame: 3 months
Change from Baseline in Glycated Haemoglobin in Subjects with Metabolic Syndrome
Time frame: 6 months
Change from Baseline in Subclinical Atherosclerosis in Subjects with Metabolic Syndrome
Time frame: 6 months
Change from Baseline in Plasma Cytokines in Subjects with Metabolic Syndrome
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Background: PubMed 27076875Martinez-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.
- Background: PubMed 23466882Corrado 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.
- Background: PubMed 18396047Lakkaraju 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.
- Background: PubMed 23939022Wang 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.
- Background: PubMed 23752315Ju 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.
- Background: PubMed 26098775Raimondo 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.
- Background: PubMed 25675136Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Montalto, MD principal investigator
University Hospital of Palermo, Palermo, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS and Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS in people with Metabolic Syndrome and Healthy Volunteers, run by University of Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Plasma Lipids in Healthy Subjects (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04698447, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.