HypercholesterolemiaNATCOLNCT03739242
Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels
A study testing Nutraceutical combination in people with Hypercholesterolemia, run by A. Menarini Industrie Farmaceutiche Riunite S.r.l. at 1 site in Italy.
Trial summary
High cholesterol is one of the major controllable risk factor for coronary heart disease. It is well demonstrated that drugs that reduce the intestinal absorption of cholesterol or block the synthesis of cholesterol or the association of both, can reduce cholesterol and reduce rate of cardiovascular events. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Nutraceutical combination
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- 12 Oct 2017to 29 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- Subjects must meet all of the following inclusion criteria:
- Age 30-75 years
- LDL-cholesterol = 115 -190 mg/dL
- Triglycerides < 400 mg/dL
- Any cardiovascular therapy should be stable for type and dose for at least three months
- Signed, written informed consent
Who cannot join
- -
- Subjects must meet none of the following exclusion criteria:
- Intolerance to any ingredient of dietary supplement
- Patients already suffering from cardiovascular diseases or at high risk of developing cardiovascular diseases
- Myopathies
- Uncontrolled diabetes mellitus based on PI judgment
Show all 15Show fewer
- Chronic renal failure [defined as estimated glomerular filtration rate (eGFR) <60ml/min/1.73m2] or liver failure [defined as aspartate aminotransferase (AST) and /or Alanine Aminotransferase (ALT) >3 upper limit of normal (ULN)]
- Body Mass Index > 32 kg/m2
- Therapy with statins or other drugs or supplements with effects on lipid metabolism
- Patients with acquired immunodeficiency
- Treatment with immunosuppressants
- Pregnant or breastfeeding women
- Women of childbearing potential not willing to use effective birth control methods
- Patients participating or having participated in another clinical trial within the previous 3 months
- Current or recent history of drug or alcohol addiction based on PI judgment
Trial locations and contacts
1 site in 1 country.
Italy1 site
Policlinico S.Orsola - Malpighi Medicina Interna Borghi
Bologna, 40138
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled, Clinical Study of the Effects of a Nutraceutical Combination on LDL Cholesterol Levels in Subjects With Sub-optimal Blood Cholesterol Levels
High cholesterol is one of the major controllable risk factor for coronary heart disease. It is well demonstrated that drugs that reduce the intestinal absorption of cholesterol or block the synthesis of cholesterol or the association of both, can reduce cholesterol and reduce rate of cardiovascular events. The trial will evaluate natural alternative to this drug approach testing the effects of a combination of phytosterol, a nutritional that reduce cholesterol absorption, and fermented red rice, a nutritional that reduce the synthesis of cholesterol. Subjects with sub optimal blood cholesterol levels, matching all the inclusion criteria and none of the exclusion criteria, will be treated for 8 weeks with a nutraceutical combination of phytosterols and fermented red rice and will have to maintain, during the entire duration of the study, the Mediterranean-style diet provided. The study will evaluate as primary objective the changes in LDL cholesterol blood levels and more in general the modulation of lipid profile and of others clinical parameters as well as the tolerability.
Read the detailed description
The study is made up of four visits distributed over a 10-weeks period:
V 1 (day -14) - Screening: After providing written informed consent, tests will be run in order to check the subject's eligibility for the study. Subjects will also be given suggestions regarding their diet (a Mediterranean-style diet is to be maintained for the entire duration of the study).
V2 (baseline) and Day 0 (randomization): After confirmation of the subject's eligibility [LDL-C and Triglycerides (TG) criteria confirmed with blood test results], eligible subjects will be randomized within 3 days to one of the two treatment groups. During this visit an endothelial reactivity test will be performed.
V3 (28 ±3 days after Day 0) - Intermediate: Blood will be drawn for tests and compliance with treatment will be assessed. V4 (28 ± 3 days after Visit 3) - End of study: Blood tests and an endothelial reactivity test will be performed and treatment compliance will be assessed.
Weight, waist circumference, Index of Central Obesity (ICO) and Body Mass Index (BMI), Hepatic Steatosis Index (HSI) and Lipid Accumulation Product (LAP) will be measured/calculated at each visit, height at Visit 1.
Heart rate and blood pressure will be measured at each visit. Adverse events (AEs) will be collected throughout the study starting from the Informed consent signature.
The study will be monitored according to the details specified in the Monitoring Plan. The monitor will have the responsibility of reviewing the ongoing study with the Investigator to verify adherence to the protocol and to deal with any problems. Case Report Form (CRF) will be checked for completeness and consistency with the source data and special attention will be dedicated to patient enrolment, obtaining signed informed consent, occurrence of AEs, product accountability, and accurate recording of variables. The confidentiality of study related documents shall be maintained at all times. The Investigator agrees to allow access to all study materials needed for the proper review of study conduct.
An independent quality audit/inspection at the study site may take place at any time during or after the study. The independent audit/inspection can be carried out by the Sponsor's independent Quality Assurance (QA), by a Health Authorities or an Ethics Committee (EC).
- Conditions
- Hypercholesterolemia
- Being tested
- Nutraceutical combination, Placebo
- Keywords
- Lipids, Cholesterol, Triglycerides, Dyslipidemia, Low density lipoprotein cholesterol, Dietary Fats, Hyperlipidemias, Dietary Supplements, Food Supplements, Nutraceuticals, Nutriceuticals
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutraceutical combinationDietary supplement
One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)
PlaceboOther
One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)
| Study group | Role | What they receive |
|---|---|---|
| Nutraceutical combination | Experimental | One film-coated tablet (1300 mg) per os per day to be taken in the evening. Each tablet contains phytosterols 800 mg, Monascus purpureus (167 mg) titrated at 3% in monacolin K (5 mg), niacin 27 mg, linear aliphatic alcohols titrated to 60% octacosanol. Receives: Dietary Supplement: Nutraceutical combination |
| Placebo | Placebo comparator | One film-coated tablet (1300 mg) per os per day to be taken in the evening. Placebo tablets identical in appearance, size, shape, weight and taste to the active product. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Blood LDL Cholesterol Level
Mean change in blood LDL cholesterol level from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Secondary outcomes (15)
Change in Total Blood Cholesterol Level
Mean change in total blood LDL cholesterol level from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Blood HDL Cholesterol Level
Mean change in blood HDL cholesterol level from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Blood Non-HDL Cholesterol Level
Mean change in blood non-HDL cholesterol level from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Blood Triglycerides Level
Mean change in blood triglycerides level from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Blood Apolipoprotein B Level
Mean change in blood apolipoprotein B level from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Total Cholesterol/HDL Cholesterol Ratio
Mean change in total cholesterol/HDL cholesterol ratio from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Total LDL Cholesterol/HDL Cholesterol Ratio
Mean change in LDL/HDL cholesterol ratio from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Pulse Volume (PV) Waveform (Endothelial Reactivity)
Mean change in Pulse Volume (PV) waveform from randomization (day 0) to V4 (week 8).
PV unit of measurement is a percent change in the PV waveform area, comparing waveforms during and before hyperemia through the equation √PV2/PV1 that relates PV at baseline (PV1) and PV during hyperemia (PV2).
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Glycemia
Mean change in Glycemia from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Aspartate Aminotransferase (AST)
Mean change in aspartate aminotransferase from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Alanine Aminotransferase (ALT)
Mean change in aspartate aminotransferase from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Gamma Glutamyl Transpeptidase (GGT)
Mean change gamma glutamyl transpeptidase (GGT) from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Serum Creatinine
Mean change in Serum Creatinine values from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Serum Uric Acid
Mean change in Serum uric acid values from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Creatine Phosphokinase (CPK)
Mean change in creatine phosphokinase (CPK) from randomization (day 0) to V4 (week 8)
Measured: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start12 Oct 2017
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Menarini Industrie Farmaceutiche Riunite S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudio Borghi, Professor, Principal investigator, Policlinico S.Orsola - Malpighi Medicina Interna Borghi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739242
- Sponsor's protocol ID
- MEIF/MOF-Col/001
- Acronym
- NATCOL
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2018
- Last updated
- 14 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cicero AFG, D'Addato S, Borghi C. A Randomized, Double-Blinded, Placebo-Controlled, Clinical Study of the Effects of a Nutraceutical Combination (LEVELIP DUO(R)) on LDL Cholesterol Levels and Lipid Pattern in Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study). Nutrients. 2020 Oct 14;12(10):3127. doi: 10.3390/nu12103127.
PubMed 33066334
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled, Clinical Study of the Effects of a Nutraceutical Combination on LDL Cholesterol Levels in Subjects With Sub-optimal Blood Cholesterol Levels
- ClinicalTrials.gov ID
- NCT03739242
- Acronym / sponsor ID
- NATCOL / MEIF/MOF-Col/001
- Conditions
- Hypercholesterolemia
- Keywords
- Lipids, Cholesterol, Triglycerides, Dyslipidemia, Low density lipoprotein cholesterol, Dietary Fats, Hyperlipidemias, Dietary Supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- A. Menarini Industrie Farmaceutiche Riunite S.r.l.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Posted 14 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High cholesterol is one of the major controllable risk factor for coronary heart disease. It is well demonstrated that drugs that reduce the intestinal absorption of cholesterol or block the synthesis of cholesterol or the association of both, can reduce cholesterol and reduce rate of cardiovascular events. The trial will evaluate natural alternative to this drug approach testing the effects of a combination of phytosterol, a nutritional that reduce cholesterol absorption, and fermented red rice, a nutritional that reduce the synthesis of cholesterol. Subjects with sub optimal blood cholesterol levels, matching all the inclusion criteria and none of the exclusion criteria, will be treated for 8 weeks with a nutraceutical combination of phytosterols and fermented red rice and will have to maintain, during the entire duration of the study, the Mediterranean-style diet provided. The study will evaluate as primary objective the changes in LDL cholesterol blood levels and more in general the modulation of lipid profile and of others clinical parameters as well as the tolerability.
Detailed description
The study is made up of four visits distributed over a 10-weeks period:
V 1 (day -14) - Screening: After providing written informed consent, tests will be run in order to check the subject's eligibility for the study. Subjects will also be given suggestions regarding their diet (a Mediterranean-style diet is to be maintained for the entire duration of the study).
V2 (baseline) and Day 0 (randomization): After confirmation of the subject's eligibility [LDL-C and Triglycerides (TG) criteria confirmed with blood test results], eligible subjects will be randomized within 3 days to one of the two treatment groups. During this visit an endothelial reactivity test will be performed.
V3 (28 ±3 days after Day 0) - Intermediate: Blood will be drawn for tests and compliance with treatment will be assessed. V4 (28 ± 3 days after Visit 3) - End of study: Blood tests and an endothelial reactivity test will be performed and treatment compliance will be assessed.
Weight, waist circumference, Index of Central Obesity (ICO) and Body Mass Index (BMI), Hepatic Steatosis Index (HSI) and Lipid Accumulation Product (LAP) will be measured/calculated at each visit, height at Visit 1.
Heart rate and blood pressure will be measured at each visit. Adverse events (AEs) will be collected throughout the study starting from the Informed consent signature.
The study will be monitored according to the details specified in the Monitoring Plan. The monitor will have the responsibility of reviewing the ongoing study with the Investigator to verify adherence to the protocol and to deal with any problems. Case Report Form (CRF) will be checked for completeness and consistency with the source data and special attention will be dedicated to patient enrolment, obtaining signed informed consent, occurrence of AEs, product accountability, and accurate recording of variables. The confidentiality of study related documents shall be maintained at all times. The Investigator agrees to allow access to all study materials needed for the proper review of study conduct.
An independent quality audit/inspection at the study site may take place at any time during or after the study. The independent audit/inspection can be carried out by the Sponsor's independent Quality Assurance (QA), by a Health Authorities or an Ethics Committee (EC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutraceutical combination | Experimental | Dietary Supplement: Nutraceutical combinationOne film-coated tablet (1300 mg) per os per day to be taken in the evening. Each tablet contains phytosterols 800 mg, Monascus purpureus (167 mg) titrated at 3% in monacolin K (5 mg), niacin 27 mg, linear aliphatic alcohols titrated to 60% octacosanol. |
| Placebo | Placebo comparator | Other: PlaceboOne film-coated tablet (1300 mg) per os per day to be taken in the evening. Placebo tablets identical in appearance, size, shape, weight and taste to the active product. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- -
- Age 30-75 years
- LDL-cholesterol = 115 -190 mg/dL
- Triglycerides < 400 mg/dL
- Any cardiovascular therapy should be stable for type and dose for at least three months
Key exclusion criteria (15 listed)
- -
- Intolerance to any ingredient of dietary supplement
- Patients already suffering from cardiovascular diseases or at high risk of developing cardiovascular diseases
- Myopathies
- Uncontrolled diabetes mellitus based on PI judgment
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 |
|---|---|---|
| Nutraceutical combinationOne tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3) | Dietary supplement | Nutraceutical combination |
| PlaceboOne tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3) | Other | Placebo |
Primary outcome
Change in Blood LDL Cholesterol Level
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Mean change in blood LDL cholesterol level from randomization (day 0) to V4 (week 8)
15 secondary outcomes
Change in Total Blood Cholesterol Level
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Blood HDL Cholesterol Level
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Blood Non-HDL Cholesterol Level
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Blood Triglycerides Level
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Blood Apolipoprotein B Level
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Total Cholesterol/HDL Cholesterol Ratio
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Total LDL Cholesterol/HDL Cholesterol Ratio
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Pulse Volume (PV) Waveform (Endothelial Reactivity)
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Glycemia
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Aspartate Aminotransferase (AST)
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Alanine Aminotransferase (ALT)
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Gamma Glutamyl Transpeptidase (GGT)
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Serum Creatinine
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Serum Uric Acid
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Change in Creatine Phosphokinase (CPK)
Time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33066334Cicero AFG, D'Addato S, Borghi C. A Randomized, Double-Blinded, Placebo-Controlled, Clinical Study of the Effects of a Nutraceutical Combination (LEVELIP DUO(R)) on LDL Cholesterol Levels and Lipid Pattern in Subjects with Sub-Optimal Blood Cholesterol Levels (NATCOL Study). Nutrients. 2020 Oct 14;12(10):3127. doi: 10.3390/nu12103127.
- 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.
Claudio Borghi, Professor principal investigator
Policlinico S.Orsola - Malpighi Medicina Interna Borghi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutraceutical combination in people with Hypercholesterolemia, run by A. Menarini Industrie Farmaceutiche Riunite S.r.l. 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 7 inclusion and 15 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 14 Oct 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?
Yes. Results are posted in the registry (first posted 14 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in Blood LDL Cholesterol Level (time frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment). 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 NCT03739242, 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 14 Oct 2019.