Metabolic SyndromeNCT03444558
Effects of Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors
A study testing Natural supplement containing chlorogenic acid and luteolin in people with Metabolic Syndrome, run by University of Palermo at 1 site in Italy.
Trial summary
Clinical trial about beneficial effects of natural ingredient containing chlorogenic acid and luteolin on liver health and conditions related to liver (such as metabolic syndrome) for general body health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Natural supplement containing chlorogenic acid and luteolin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 28 Feb 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged >18 years with the metabolic syndrome (as defined by the international criteria: Alberti KG, et al. Circulation. 2009; 120: 1640-5);
- BMI> 25 kg/m^2;
- Subjects able to swallow whole tablets;
- Informed consent obtained prior to any study-related activities.
Who cannot join
- Pregnancy or willingness to become pregnant;
- Severe liver dysfunction (ALT >2.5 times upper limit of normal);
- Severe renal failure (eGFR<60 mL/min/1.73 m2 using the MDRD formula);
- Severe infections at the discretion of the investigator (such as HIV, HBV and HCV);
- History or presence of malignant neoplasms within the last 5 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome
Clinical trial about beneficial effects of natural ingredient containing chlorogenic acid and luteolin on liver health and conditions related to liver (such as metabolic syndrome) for general body health.
Read the detailed description
This is one randomized, double-blind, placebo-controlled study. The purpose of the present study is to evaluate and/or elucidate the role of the natural supplement, containing chlorogenic acid (10-12%) and luteinyl-7-glucoside (2-4%), on cardio-metabolic risk factors.
The research hypothesis is to evaluate whether natural supplement containing chlorogenic acid and luteolin (Puraltilix, BIONAP SRL, Catania, Italy) may improve several cardio-metabolic parameters in subjects with the metabolic syndrome.
All subjects will be evaluated at baseline and after 6 months of treatment (with natural supplement or placebo).
- Conditions
- Metabolic Syndrome
- Being tested
- Natural supplement containing chlorogenic acid and luteolin, Placebo (without any active ingredients)
- Keywords
- metabolic parameters, cardio-metabolic parameters
- 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 chlorogenic acid and luteolinDietary supplement
50 eligible subjects will receive natural supplement as the oral pills at a fixed dose of 1 pill/day (450 mg/day) for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.
Placebo (without any active ingredients)Other
50 eligible subjects will receive placebo (without any active ingredients) at a fixed dose of 1 pill/day for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Experimental | 50 subjects with the metabolic syndrome receiving natural supplement containing chlorogenic acid and luteolin (450 mg/die) Receives: Dietary Supplement: Natural supplement containing chlorogenic acid and luteolin |
| Placebo | Placebo comparator | 50 subjects with the metabolic syndrome receiving placebo (without any active ingredients) Receives: Other: Placebo (without any active ingredients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI)
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including body weight (kg) and height (m) that will be combined to report BMI in kg/m^2.
Measured: Change from baseline to 6 months of the supplementation
Effect of natural supplement on metabolic parameters including waist circumference
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including waist circumference (cm).
Measured: Change from baseline to 6 months of the supplementation
Effect of natural supplement on metabolic parameters including plasma lipids
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol HDL-C) (mmol/l), while low-density lipoprotein cholesterol (LDL-C) will be calculated using the Friedewald formula.
Measured: Change from baseline to 6 months of the supplementation
Effect of natural supplement on metabolic parameters including glucose metabolism parameters
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma glycemia (mmol/l).
Measured: Change from baseline to 6 months of the supplementation
Effect of natural supplement on metabolic parameters including plasma insulinemia and HOMA (homeostatic model assessment) index
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma insulinemia (pmol/L) that with glycemia will be combined to report HOMA index.
Measured: Change from baseline to 6 months of the supplementation
Secondary outcomes (4)
Effect of natural supplement on cardio-metabolic parameters including plasma cytokines
Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including plasma cytokines (inflammatory markers and adipokines) (pg/ml), that will be assessed using available enzyme-linked immunosorbent assay (ELISA) kits.
Measured: Change from baseline to 6 months of the supplementation
Effect of natural supplement on cardio-metabolic parameters including plasma lipoproteins
Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including atherogenic lipoproteins as well as the analysis of the full spectrum of lipoprotein subclasses by gel electrophoresis.
Measured: Change from baseline to 6 months of the supplementation
Effect of natural supplement on cardio-metabolic parameters including subclinical atherosclerosis
Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including subclinical atherosclerosis assessed by carotid intima-media thickness (CIMT) (mm).
Measured: Change from baseline to 6 months of the supplementation
Effect of natural supplement on cardio-metabolic parameters including fatty liver index
Effect of natural supplement containing chlorogenic acid and luteolin on cardio-metabolic parameters, including fatty liver index, a noninvasive method used for steatosis detection and quantification.
Measured: Change from baseline to 6 months of the supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start1 Jun 2017
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Catania
- Responsible party
- Principal investigator, Manfredi Rizzo, University of Palermo
- Investigators
- Manfredi Rizzo, MD, PhD, Principal investigator, University Hospital of Palermo, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444558
- Sponsor's protocol ID
- Natural Supplement
- Status last verified
- Oct 2018
- First submitted
- 5 Jun 2017
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
PubMed 19805654
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Natural Supplement Containing Chlorogenic Acid and Luteolin on Cardio-metabolic Risk Factors in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03444558
- Acronym / sponsor ID
- Natural Supplement
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic parameters, cardio-metabolic parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Collaborators
- University of Catania
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 23 Feb 2018 (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 ingredient containing chlorogenic acid and luteolin on liver health and conditions related to liver (such as metabolic syndrome) for general body health.
Detailed description
This is one randomized, double-blind, placebo-controlled study. The purpose of the present study is to evaluate and/or elucidate the role of the natural supplement, containing chlorogenic acid (10-12%) and luteinyl-7-glucoside (2-4%), on cardio-metabolic risk factors.
The research hypothesis is to evaluate whether natural supplement containing chlorogenic acid and luteolin (Puraltilix, BIONAP SRL, Catania, Italy) may improve several cardio-metabolic parameters in subjects with the metabolic syndrome.
All subjects will be evaluated at baseline and after 6 months of treatment (with natural supplement or placebo).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | Experimental | Dietary Supplement: Natural supplement containing chlorogenic acid and luteolin50 subjects with the metabolic syndrome receiving natural supplement containing chlorogenic acid and luteolin (450 mg/die) |
| Placebo | Placebo comparator | Other: Placebo (without any active ingredients)50 subjects with the metabolic syndrome receiving placebo (without any active ingredients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged >18 years with the metabolic syndrome (as defined by the international criteria: Alberti KG, et al. Circulation. 2009; 120: 1640-5);
- BMI> 25 kg/m^2;
- Subjects able to swallow whole tablets;
- Informed consent obtained prior to any study-related activities.
Key exclusion criteria (5 listed)
- Pregnancy or willingness to become pregnant;
- Severe liver dysfunction (ALT >2.5 times upper limit of normal);
- Severe renal failure (eGFR<60 mL/min/1.73 m2 using the MDRD formula);
- Severe infections at the discretion of the investigator (such as HIV, HBV and HCV);
- History or presence of malignant neoplasms within the last 5 years.
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 chlorogenic acid and luteolin50 eligible subjects will receive natural supplement as the oral pills at a fixed dose of 1 pill/day (450 mg/day) for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study. | Dietary supplement | Dietary Supplement |
| Placebo (without any active ingredients)50 eligible subjects will receive placebo (without any active ingredients) at a fixed dose of 1 pill/day for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study. | Other | Placebo |
Primary outcome
Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI)
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including body weight (kg) and height (m) that will be combined to report BMI in kg/m^2.
Effect of natural supplement on metabolic parameters including waist circumference
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including waist circumference (cm).
Effect of natural supplement on metabolic parameters including plasma lipids
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma lipids (total cholesterol, triglycerides, high-density lipoprotein cholesterol HDL-C) (mmol/l), while low-density lipoprotein cholesterol (LDL-C) will be calculated using the Friedewald formula.
Effect of natural supplement on metabolic parameters including glucose metabolism parameters
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma glycemia (mmol/l).
Effect of natural supplement on metabolic parameters including plasma insulinemia and HOMA (homeostatic model assessment) index
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement containing chlorogenic acid and luteolin on metabolic parameters, including plasma insulinemia (pmol/L) that with glycemia will be combined to report HOMA index.
4 secondary outcomes
Effect of natural supplement on cardio-metabolic parameters including plasma cytokines
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement on cardio-metabolic parameters including plasma lipoproteins
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement on cardio-metabolic parameters including subclinical atherosclerosis
Time frame: Change from baseline to 6 months of the supplementation
Effect of natural supplement on cardio-metabolic parameters including fatty liver index
Time frame: Change from baseline to 6 months of the supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Background: PubMed 19805654Alberti KG, Eckel RH, Grundy SM, Zimmet PZ, Cleeman JI, Donato KA, Fruchart JC, James WP, Loria CM, Smith SC Jr; International Diabetes Federation Task Force on Epidemiology and Prevention; Hational Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; International Association for the Study of Obesity. Harmonizing the metabolic syndrome: a joint interim statement of the International Diabetes Federation Task Force on Epidemiology and Prevention; National Heart, Lung, and Blood Institute; American Heart Association; World Heart Federation; International Atherosclerosis Society; and International Association for the Study of Obesity. Circulation. 2009 Oct 20;120(16):1640-5. doi: 10.1161/CIRCULATIONAHA.109.192644. Epub 2009 Oct 5.
- 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.
Manfredi Rizzo, MD, PhD principal investigator
University Hospital of 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 chlorogenic acid and luteolin in people with Metabolic Syndrome, 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 4 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: finished, as of the sponsor's last update on 24 Oct 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effect of natural supplement on metabolic parameters including body weight and Body Mass Index (BMI) (time frame: Change from baseline to 6 months of the supplementation). The study lists 5 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 NCT03444558, which also lists 1 linked publication.
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 24 Oct 2018.