Cardiovascular Risk FactorsLopiWEBNCT02898805
Effects of LopiGLIK® on Cardiovascular Risk
A study testing Prescribed Diet, LopiGLIK® and Armolipid Plus in people with Cardiovascular Risk Factors, run by Federico II University at 1 site in Italy.
Trial summary
The study is designed to compare the effects of two combination of nutraceuticals: Armolipid Plus® and LopiGLIK® (Akademy Pharma), a new supplement that, in addition to Berberine and Red Rice, contains Morus Alba's extract. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors
- What is being tested?
- Prescribed Diet, LopiGLIK® and Armolipid Plus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to 1 Dec 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Total Cholesterol<300 mg/dL
- Total Cholesterol>200 mg/dL
- Cardiovascular Risk<20%
Who cannot join
- Pregnancy
- Documented intolerance to one or more 'components LOPIGLIK / Armolipid PLUS
- Previous cardiovascular events
- Familiar severe dyslipidemia
- Familiar high cardiovascular risk Hepatic or muscular disorders Subjects receiving lipid-lowering drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a New Combination of Nutraceutics (LopiGLIK®) on Cardiovascular Risk
The study is designed to compare the effects of two combination of nutraceuticals: Armolipid Plus® and LopiGLIK® (Akademy Pharma), a new supplement that, in addition to Berberine and Red Rice, contains Morus Alba's extract. The study will analyze the impact of 16 week treatment with one of the combinations, according to a randomized scheme, on metabolic parameters in dyslipidemic subjects that do not require or not tolerate a statin therapy. In particular, it will assess the ability of the two combinations to reduce the levels of total and LDL cholesterol, HbA1C, glicaemia and insulin and increase those of HDL cholesterol.
Read the detailed description
The experimental design involves the construction of a multi-center, controlled, randomized, single-blind, versus Armolipid Plus®.
Patients with mild hypercholesterolemia, of both sexes and aged between 18 and 75 years, will be recruited, from the beginning of the study and for the next 2 weeks, from 30 Cv specialists and/or GPs (25 patients each).
The subjects will be enrolled in the 50/50% male/female ratio ± 10% comparable for age, in order to obtain a proper comparison between groups with similar demographic characteristics or not statistically different.
The subjects, selected on the basis of inclusion and exclusion criteria, will be divided into two groups, subjected to centralized randomization at the "Diagnosis and Treatment of hypertension Center" to receive one of two different treatments, a tablet/day of the new nutraceutical LopiGLIK® (Akademy Pharma) containing Morus Alba, immediately after a meal, vs. a tablet/day of Armolipid Plus, always immediately after the meal. During the first two weeks both groups will follow the prescribed diet and assume the placebo. At the end, blood tests (traditional metabolic parameters, blood glucose, HbA1C, fasting insulin, transaminase levels, CPK) and the endothelial function will be assesed. During the next 16 weeks a group will assume LopiGLIK® (Akademy Pharma) containing Morus Alba, the other will assume Armolipid Plus and everyone will continue to follow the prescribed diet. At the end of this period blood tests will be repeated. Tablets of Armolipid Plus, LopiGLIK® and placebo will be provided by Akademy Pharma free of charge
- Conditions
- Cardiovascular Risk Factors
- Being tested
- Placebo, Prescribed Diet, LopiGLIK®, Armolipid Plus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Prescribed DietOther
LopiGLIK®Dietary supplement
Armolipid PlusDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| LopiGLIK® | Experimental | first two weeks: Placebo + prescribed Diet then 16 weeks LopiGLIK® a tablet/day after a meal + Diet Receives: Other: Placebo; Other: Prescribed Diet; Dietary Supplement: LopiGLIK® |
| Armolipid Plus | Active comparator | first two weeks: Placebo + prescribed Diet then 16 weeks Armolipid Plus a tablet/day after a meal + Diet Receives: Other: Placebo; Other: Prescribed Diet; Dietary Supplement: Armolipid Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of LDL-Cholesterol levels
Measured: 16 weeks
Secondary outcomes (3)
Increasing of HDL-Cholesterol levels
Measured: 16 weeks
Reduction of HbA1c levels
Measured: 16 weeks
Reduction of fastin insuline levels
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Trimarco, Federico II University
- Investigators
- Bruno Trimarco, Professor, Principal investigator, FEDERICO II UNIVERSITY - NAPLES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898805
- Sponsor's protocol ID
- AKP_3
- Acronym
- LopiWEB
- Status last verified
- Jul 2019
- First submitted
- 8 Sep 2016
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data available to principal investigator
Publications
Trimarco V, Izzo R, Stabile E, Rozza F, Santoro M, Manzi MV, Serino F, Schiattarella GG, Esposito G, Trimarco B. Effects of a new combination of nutraceuticals with Morus alba on lipid profile, insulin sensitivity and endotelial function in dyslipidemic subjects. A cross-over, randomized, double-blind trial. High Blood Press Cardiovasc Prev. 2015 Jun;22(2):149-54. doi: 10.1007/s40292-015-0087-2. Epub 2015 Apr 14.
PubMed 25870124Carrizzo A, Ambrosio M, Damato A, Madonna M, Storto M, Capocci L, Campiglia P, Sommella E, Trimarco V, Rozza F, Izzo R, Puca AA, Vecchione C. Morus alba extract modulates blood pressure homeostasis through eNOS signaling. Mol Nutr Food Res. 2016 Oct;60(10):2304-2311. doi: 10.1002/mnfr.201600233. Epub 2016 Jun 27.
PubMed 27234065Manfrin A, Trimarco V, Manzi MV, Rozza F, Izzo R. A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK(R)) lowering cardiovascular disease risk. Clinicoecon Outcomes Res. 2018 Oct 8;10:601-609. doi: 10.2147/CEOR.S172838. eCollection 2018.
PubMed 30349338
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a New Combination of Nutraceutics (LopiGLIK®) on Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT02898805
- Acronym / sponsor ID
- LopiWEB / AKP_3
- Conditions
- Cardiovascular Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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.
The study is designed to compare the effects of two combination of nutraceuticals: Armolipid Plus® and LopiGLIK® (Akademy Pharma), a new supplement that, in addition to Berberine and Red Rice, contains Morus Alba's extract. The study will analyze the impact of 16 week treatment with one of the combinations, according to a randomized scheme, on metabolic parameters in dyslipidemic subjects that do not require or not tolerate a statin therapy. In particular, it will assess the ability of the two combinations to reduce the levels of total and LDL cholesterol, HbA1C, glicaemia and insulin and increase those of HDL cholesterol.
Detailed description
The experimental design involves the construction of a multi-center, controlled, randomized, single-blind, versus Armolipid Plus®.
Patients with mild hypercholesterolemia, of both sexes and aged between 18 and 75 years, will be recruited, from the beginning of the study and for the next 2 weeks, from 30 Cv specialists and/or GPs (25 patients each).
The subjects will be enrolled in the 50/50% male/female ratio ± 10% comparable for age, in order to obtain a proper comparison between groups with similar demographic characteristics or not statistically different.
The subjects, selected on the basis of inclusion and exclusion criteria, will be divided into two groups, subjected to centralized randomization at the "Diagnosis and Treatment of hypertension Center" to receive one of two different treatments, a tablet/day of the new nutraceutical LopiGLIK® (Akademy Pharma) containing Morus Alba, immediately after a meal, vs. a tablet/day of Armolipid Plus, always immediately after the meal. During the first two weeks both groups will follow the prescribed diet and assume the placebo. At the end, blood tests (traditional metabolic parameters, blood glucose, HbA1C, fasting insulin, transaminase levels, CPK) and the endothelial function will be assesed. During the next 16 weeks a group will assume LopiGLIK® (Akademy Pharma) containing Morus Alba, the other will assume Armolipid Plus and everyone will continue to follow the prescribed diet. At the end of this period blood tests will be repeated. Tablets of Armolipid Plus, LopiGLIK® and placebo will be provided by Akademy Pharma free of charge
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LopiGLIK® | Experimental | Other: Placebo, Other: Prescribed Diet, Dietary Supplement: LopiGLIK®first two weeks: Placebo + prescribed Diet then 16 weeks LopiGLIK® a tablet/day after a meal + Diet |
| Armolipid Plus | Active comparator | Other: Placebo, Other: Prescribed Diet, Dietary Supplement: Armolipid Plusfirst two weeks: Placebo + prescribed Diet then 16 weeks Armolipid Plus a tablet/day after a meal + Diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total Cholesterol<300 mg/dL
- Total Cholesterol>200 mg/dL
- Cardiovascular Risk<20%
Key exclusion criteria (5 listed)
- Pregnancy
- Documented intolerance to one or more 'components LOPIGLIK / Armolipid PLUS
- Previous cardiovascular events
- Familiar severe dyslipidemia
- Familiar high cardiovascular risk Hepatic or muscular disorders Subjects receiving lipid-lowering drugs
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 |
|---|---|---|
| Placebo | Other | Armolipid Plus, LopiGLIK® |
| Prescribed Diet | Other | Armolipid Plus, LopiGLIK® |
| LopiGLIK® | Dietary supplement | LopiGLIK® |
| Armolipid Plus | Dietary supplement | Armolipid Plus |
Primary outcome
Reduction of LDL-Cholesterol levels
Time frame: 16 weeks
3 secondary outcomes
Increasing of HDL-Cholesterol levels
Time frame: 16 weeks
Reduction of HbA1c levels
Time frame: 16 weeks
Reduction of fastin insuline levels
Time frame: 16 weeks
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 30 Jul 2019.
- Results publication: PubMed 25870124Trimarco V, Izzo R, Stabile E, Rozza F, Santoro M, Manzi MV, Serino F, Schiattarella GG, Esposito G, Trimarco B. Effects of a new combination of nutraceuticals with Morus alba on lipid profile, insulin sensitivity and endotelial function in dyslipidemic subjects. A cross-over, randomized, double-blind trial. High Blood Press Cardiovasc Prev. 2015 Jun;22(2):149-54. doi: 10.1007/s40292-015-0087-2. Epub 2015 Apr 14.
- Results publication: PubMed 27234065Carrizzo A, Ambrosio M, Damato A, Madonna M, Storto M, Capocci L, Campiglia P, Sommella E, Trimarco V, Rozza F, Izzo R, Puca AA, Vecchione C. Morus alba extract modulates blood pressure homeostasis through eNOS signaling. Mol Nutr Food Res. 2016 Oct;60(10):2304-2311. doi: 10.1002/mnfr.201600233. Epub 2016 Jun 27.
- Derived from this study: PubMed 30349338Manfrin A, Trimarco V, Manzi MV, Rozza F, Izzo R. A single blind, multicenter, randomized controlled trial to evaluate the effectiveness and cost of a novel nutraceutical (LopiGLIK(R)) lowering cardiovascular disease risk. Clinicoecon Outcomes Res. 2018 Oct 8;10:601-609. doi: 10.2147/CEOR.S172838. eCollection 2018.
- Individual participant dataSharing planned: Yes. Data available to principal investigator
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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.
Bruno Trimarco, Professor principal investigator
FEDERICO II UNIVERSITY - NAPLES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prescribed Diet, LopiGLIK® and Armolipid Plus in people with Cardiovascular Risk Factors, run by Federico II University 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 3 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 30 Jul 2019. 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. 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?
Reduction of LDL-Cholesterol levels (time frame: 16 weeks). 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 NCT02898805, which also lists 3 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 30 Jul 2019.