Cardiovascular Risk FactorNCT03340285
Effects of a New Combination of Nutraceuticals (AkP06) Without Monacolin K on Plasma Lipids and Glucose
A study testing AkP06 in people with Cardiovascular Risk Factor, run by Federico II University at 1 site in Italy.
Trial summary
The study is designed evaluate the effects of a new combination of nutraceuticals (AkP 06) without Monacolin K on lipid and glucose metabolism. The study will analyze the impact of 4 weeks treatment with Akp06 or placebo, according to a randomized scheme, on metabolic parameters in dyslipidemic subjects that do not… 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 Factor
- What is being tested?
- AkP06
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2017to 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 of AkP06
- 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: Randomized, Single-blind, Parallel-group, Placebo-controlled Study to Evaluate the Effect of a New Combination of Nutraceuticals (AkP06) Without Monacolin K on Plasma Lipids and Glucose
The study is designed evaluate the effects of a new combination of nutraceuticals (AkP 06) without Monacolin K on lipid and glucose metabolism.
The study will analyze the impact of 4 weeks treatment with Akp06 or placebo, 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 AkP 06 to reduce the plasma levels of LDL cholesterol, HbA1C, glicaemia and fasting insulin and to increase those of HDL cholesterol.
In addition, effects on serum transaminase and creatine phosphokinase (CPK) concentration will be evaluated.
Read the detailed description
The experimental design involves the construction of a placebo-controlled, randomized, single-blind, parallel-groups.
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 at the outpatients Hypertension Clinic.
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, to a computer based randomization scheme to receive one of two different treatments, two tablet/day before meals of the new nutraceutical AkP06 (Akademy Pharma) containing Morus Alba and without Monacolin K, vs. two tablet/day of placebo, always before meals. During the first two weeks both groups will follow the prescribed diet and assume placebo tablets. At the end, blood tests (traditional metabolic parameters, blood glucose, HbA1C, fasting insulin, transaminase levels, CPK) will be performed. During the next 4 weeks a group will assume AkP06 (Akademy Pharma) containing Morus Alba and without Monakolin K, the other will assume placebo and everyone will continue to follow the prescribed diet. At the end of this period blood tests will be repeated. Tablets of AkP06 and placebo will be provided by Akademy Pharma free of charge
- Conditions
- Cardiovascular Risk Factor
- Being tested
- AkP06, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AkP06Dietary supplement
first 2 weeks: Placebo + Diet then 4 weeks AkP06 two tablet/day before meals + Diet
PlaceboDietary supplement
first 2 weeks: Placebo + Diet then 4 weeks placebo two tablet/day before meals + Diet
| Study group | Role | What they receive |
|---|---|---|
| AkP06 | Experimental | first two weeks: Placebo + prescribed Diet then 4 weeks AkP06 two tablet/day before meals + Diet Receives: Dietary Supplement: AkP06 |
| Placebo | Placebo comparator | first two weeks: Placebo + prescribed Diet then 4 weeks Placebo two tablet/day before meals + Diet Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of LDL-Cholesterol levels
Measured: 4 weeks
Secondary outcomes (5)
Increasing of HDL-Cholesterol levels
Measured: 4 weeks
Reduction of HbA1c levels
Measured: 4 weeks
Reduction of fastin insuline levels
Measured: 4 weeks
No alteration of transaminase levels
Measured: 4 weeks
No alteration of CPK levels
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Dec 2017
- Primary completion31 Mar 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Risk FactorStudies 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
- 45 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
- NCT03340285
- Sponsor's protocol ID
- AkP_6
- Status last verified
- Jul 2019
- First submitted
- 8 Nov 2017
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
- Randomized, Single-blind, Parallel-group, Placebo-controlled Study to Evaluate the Effect of a New Combination of Nutraceuticals (AkP06) Without Monacolin K on Plasma Lipids and Glucose
- ClinicalTrials.gov ID
- NCT03340285
- Acronym / sponsor ID
- AkP_6
- Conditions
- Cardiovascular Risk Factor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 13 Nov 2017 (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.
The study is designed evaluate the effects of a new combination of nutraceuticals (AkP 06) without Monacolin K on lipid and glucose metabolism.
The study will analyze the impact of 4 weeks treatment with Akp06 or placebo, 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 AkP 06 to reduce the plasma levels of LDL cholesterol, HbA1C, glicaemia and fasting insulin and to increase those of HDL cholesterol.
In addition, effects on serum transaminase and creatine phosphokinase (CPK) concentration will be evaluated.
Detailed description
The experimental design involves the construction of a placebo-controlled, randomized, single-blind, parallel-groups.
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 at the outpatients Hypertension Clinic.
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, to a computer based randomization scheme to receive one of two different treatments, two tablet/day before meals of the new nutraceutical AkP06 (Akademy Pharma) containing Morus Alba and without Monacolin K, vs. two tablet/day of placebo, always before meals. During the first two weeks both groups will follow the prescribed diet and assume placebo tablets. At the end, blood tests (traditional metabolic parameters, blood glucose, HbA1C, fasting insulin, transaminase levels, CPK) will be performed. During the next 4 weeks a group will assume AkP06 (Akademy Pharma) containing Morus Alba and without Monakolin K, the other will assume placebo and everyone will continue to follow the prescribed diet. At the end of this period blood tests will be repeated. Tablets of AkP06 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 |
|---|---|---|
| AkP06 | Experimental | Dietary Supplement: AkP06first two weeks: Placebo + prescribed Diet then 4 weeks AkP06 two tablet/day before meals + Diet |
| Placebo | Placebo comparator | Dietary Supplement: Placebofirst two weeks: Placebo + prescribed Diet then 4 weeks Placebo two tablet/day before meals + 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 of AkP06
- 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 |
|---|---|---|
| AkP06first 2 weeks: Placebo + Diet then 4 weeks AkP06 two tablet/day before meals + Diet | Dietary supplement | AkP06 |
| Placebofirst 2 weeks: Placebo + Diet then 4 weeks placebo two tablet/day before meals + Diet | Dietary supplement | Placebo |
Primary outcome
Reduction of LDL-Cholesterol levels
Time frame: 4 weeks
5 secondary outcomes
Increasing of HDL-Cholesterol levels
Time frame: 4 weeks
Reduction of HbA1c levels
Time frame: 4 weeks
Reduction of fastin insuline levels
Time frame: 4 weeks
No alteration of transaminase levels
Time frame: 4 weeks
No alteration of CPK levels
Time frame: 4 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.
- Individual participant dataSharing planned: Yes
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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 AkP06 in people with Cardiovascular Risk Factor, 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. 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?
Reduction of LDL-Cholesterol levels (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.