AtherosclerosisPhase 4NCT02422927
Nutraceutical Combination in Patients With Low-grade Systemic Inflammation
A Phase 4 study testing Nutraceutical Combination in people with Atherosclerosis and Inflammation, run by University Of Perugia.
Trial summary
The investigators tested if a nutraceutical combination with red yeast rice, berberine and policosanol (NC) can significantly modify inflammation, lipid profile and markers of endothelial injury (endothelial microparticles) in subjects with elevated levels of high-sensitivity C-reactive protein (hsCRP). Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Atherosclerosis, Inflammation, Hypercholesterolemia
- What is being tested?
- Nutraceutical Combination
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Feb 2015
- Phase
- Phase 4
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- LDL cholesterol <160 mg/dl (4,14 mmol/l);
- hsCRP >2 mg/L;
Who cannot join
- triglycerides >500 mg/dL (5.6 mmol/L);
- current or previous treatment with lipid-lowering drugs or with other drugs supposed to modify vascular damage and/or repair (antiplatelet, anti-hypertensive and antioxidant drugs);
- current or previous treatment with hormone replacement therapy for menopause vasomotor symptoms;
- evidence of liver dysfunction or alanine-aminotransferase (ALT) levels twice above the upper normal limit;
- creatin-kinase (CK) levels thrice above the upper normal limit
- history or clinical evidence of previous or current cardiovascular disease;
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- presence of strong cardiovascular risk factors such as: serum creatinine levels >2 mg/dL, diabetes mellitus, uncontrolled systemic arterial hypertension (systolic blood pressure >190 mg/dL or diastolic blood pressure >100 mg/dL); history of cancer in the former 5 years before recruitment; not adequately treated hypothyroidism (TSH levels >1,5 times the upper normal limit);
- history of malignancy in the previous 5 years before screening;
- not adequately treated hypothyroidism (TSH levels >1,5 times the upper normal limit);
- previous or current alcohol or drugs abuse;
- history or clinical evidence of chronic inflammatory disease such as severe arthritis, systemic lupus erythematosus or chronic inflammatory bowel disease;
- current or previous use of immunosuppressant agents or long term glucocorticoids
- history or clinical evidence of any severe concomitant disease which may compromise subject's safety or its possibility to carry out the study.
About this study
Official title: Effect of a Nutraceutical Combination on Endothelial Injury and C-reactive Protein in Patients With Low-grade Systemic Inflammation
The investigators tested if a nutraceutical combination with red yeast rice, berberine and policosanol (NC) can significantly modify inflammation, lipid profile and markers of endothelial injury (endothelial microparticles) in subjects with elevated levels of high-sensitivity C-reactive protein (hsCRP).
Read the detailed description
Will be included in the study 100 subjects with suboptimal LDL cholesterol levels (LDL 100-160 mg / dL) and hsCRP levels> 2 mg / L, divided into two groups of equal numbers, matched by by sex and age, randomized to receive a nutraceutical combination containing red yeast 200 mg, berberine 500 mg and policosanol 10 mg (NC) in combination with a low-cholesterol diet (<200 mg / day) or a low-cholesterol diet only (Standard of Care - SOC).
All subjects at the time of inclusion in the study protocol will be prescribed the SOC for a period of 30 days (Lipid Stabilization Period: LSP); After 30 days LSP it will be performed randomization in the two intervention arms: NC + SOC or SOC.
- Conditions
- Atherosclerosis, Inflammation, Hypercholesterolemia
- Being tested
- Nutraceutical Combination, Standard of Care, Placebo
- Keywords
- C-Reactive Protein, Endothelial Microparticles, Endothelium, Nutraceutical, Cholesterol
- Medical subject headings
- Atherosclerosis, Inflammation, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutraceutical CombinationDietary supplement
Also called Armolipid Plus, Rottapharm-Madaus
red yeast rice extract 200 mg (equivalent to 3 mg monacolins), policosanol 10 mg, berberine 500 mg, 0.2 mg folic acid, coenzyme Q10 2 mg, and astaxanthin 0.5 mg once daily
Standard of CareOther
low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care + Placebo | Placebo comparator | low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + once daily placebo Receives: Other: Standard of Care; Other: Placebo |
| Nutraceutical combination | Active comparator | low-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + Nutraceutical combination Receives: Dietary Supplement: Nutraceutical Combination; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in LDL cholesterol at 3 months
Measured: 3 months after treatment randomization
Secondary outcomes (2)
Change from Baseline in Circulating endothelial microparticles at 3 months
Measured: 3 months after treatment randomization
Change from Baseline in C-reactive protein at 3 months
Measured: 3 months after treatment randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionJan 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Pirro, University Of Perugia
- Investigators
- Matteo Pirro, MD, PhD, Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422927
- Sponsor's protocol ID
- UPerugia01
- Status last verified
- Apr 2015
- First submitted
- 13 Apr 2015
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
McGorrian C, Yusuf S, Islam S, Jung H, Rangarajan S, Avezum A, Prabhakaran D, Almahmeed W, Rumboldt Z, Budaj A, Dans AL, Gerstein HC, Teo K, Anand SS; INTERHEART Investigators. Estimating modifiable coronary heart disease risk in multiple regions of the world: the INTERHEART Modifiable Risk Score. Eur Heart J. 2011 Mar;32(5):581-9. doi: 10.1093/eurheartj/ehq448. Epub 2010 Dec 22.
PubMed 21177699Pirro M, Bergeron J, Dagenais GR, Bernard PM, Cantin B, Despres JP, Lamarche B. Age and duration of follow-up as modulators of the risk for ischemic heart disease associated with high plasma C-reactive protein levels in men. Arch Intern Med. 2001 Nov 12;161(20):2474-80. doi: 10.1001/archinte.161.20.2474.
PubMed 11700160Gerli R, Sherer Y, Vaudo G, Schillaci G, Gilburd B, Giordano A, Bocci EB, Allegrucci R, Marchesi S, Mannarino E, Shoenfeld Y. Early atherosclerosis in rheumatoid arthritis: effects of smoking on thickness of the carotid artery intima media. Ann N Y Acad Sci. 2005 Jun;1051:281-90. doi: 10.1196/annals.1361.069.
PubMed 16126969Gerli R, Vaudo G, Bocci EB, Schillaci G, Alunno A, Luccioli F, Hijazi R, Mannarino E, Shoenfeld Y. Functional impairment of the arterial wall in primary Sjogren's syndrome: combined action of immunologic and inflammatory factors. Arthritis Care Res (Hoboken). 2010 May;62(5):712-8. doi: 10.1002/acr.20117.
PubMed 20191479St-Pierre AC, Cantin B, Bergeron J, Pirro M, Dagenais GR, Despres JP, Lamarche B. Inflammatory markers and long-term risk of ischemic heart disease in men A 13-year follow-up of the Quebec Cardiovascular Study. Atherosclerosis. 2005 Oct;182(2):315-21. doi: 10.1016/j.atherosclerosis.2005.02.009.
PubMed 16159604Ridker PM, Rifai N, Clearfield M, Downs JR, Weis SE, Miles JS, Gotto AM Jr; Air Force/Texas Coronary Atherosclerosis Prevention Study Investigators. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N Engl J Med. 2001 Jun 28;344(26):1959-65. doi: 10.1056/NEJM200106283442601.
PubMed 11430324Pirro M, Schillaci G, Paltriccia R, Bagaglia F, Menecali C, Mannarino MR, Capanni M, Velardi A, Mannarino E. Increased ratio of CD31+/CD42- microparticles to endothelial progenitors as a novel marker of atherosclerosis in hypercholesterolemia. Arterioscler Thromb Vasc Biol. 2006 Nov;26(11):2530-5. doi: 10.1161/01.ATV.0000243941.72375.15. Epub 2006 Aug 31.
PubMed 16946129Pirro M, Schillaci G, Bagaglia F, Menecali C, Paltriccia R, Mannarino MR, Capanni M, Velardi A, Mannarino E. Microparticles derived from endothelial progenitor cells in patients at different cardiovascular risk. Atherosclerosis. 2008 Apr;197(2):757-67. doi: 10.1016/j.atherosclerosis.2007.07.012. Epub 2007 Aug 27.
PubMed 17720166Affuso F, Ruvolo A, Micillo F, Sacca L, Fazio S. Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Nutr Metab Cardiovasc Dis. 2010 Nov;20(9):656-61. doi: 10.1016/j.numecd.2009.05.017. Epub 2009 Aug 20.
PubMed 19699071
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Nutraceutical Combination on Endothelial Injury and C-reactive Protein in Patients With Low-grade Systemic Inflammation
- ClinicalTrials.gov ID
- NCT02422927
- Acronym / sponsor ID
- UPerugia01
- Conditions
- Atherosclerosis, Inflammation, Hypercholesterolemia
- Keywords
- C-Reactive Protein, Endothelial Microparticles, Endothelium, Nutraceutical, Cholesterol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Apr 2015 (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 investigators tested if a nutraceutical combination with red yeast rice, berberine and policosanol (NC) can significantly modify inflammation, lipid profile and markers of endothelial injury (endothelial microparticles) in subjects with elevated levels of high-sensitivity C-reactive protein (hsCRP).
Detailed description
Will be included in the study 100 subjects with suboptimal LDL cholesterol levels (LDL 100-160 mg / dL) and hsCRP levels> 2 mg / L, divided into two groups of equal numbers, matched by by sex and age, randomized to receive a nutraceutical combination containing red yeast 200 mg, berberine 500 mg and policosanol 10 mg (NC) in combination with a low-cholesterol diet (<200 mg / day) or a low-cholesterol diet only (Standard of Care - SOC).
All subjects at the time of inclusion in the study protocol will be prescribed the SOC for a period of 30 days (Lipid Stabilization Period: LSP); After 30 days LSP it will be performed randomization in the two intervention arms: NC + SOC or SOC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care + Placebo | Placebo comparator | Other: Standard of Care, Other: Placebolow-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + once daily placebo |
| Nutraceutical combination | Active comparator | Dietary Supplement: Nutraceutical Combination, Other: Standard of Carelow-cholesterol/low-saturated fat diet and a regular aerobic physical activity schedule + Nutraceutical combination |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- LDL cholesterol <160 mg/dl (4,14 mmol/l);
- hsCRP >2 mg/L;
Key exclusion criteria (13 listed)
- triglycerides >500 mg/dL (5.6 mmol/L);
- current or previous treatment with lipid-lowering drugs or with other drugs supposed to modify vascular damage and/or repair (antiplatelet, anti-hypertensive and antioxidant drugs);
- current or previous treatment with hormone replacement therapy for menopause vasomotor symptoms;
- evidence of liver dysfunction or alanine-aminotransferase (ALT) levels twice above the upper normal limit;
- creatin-kinase (CK) levels thrice above the upper normal limit
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 CombinationAlso: Armolipid Plus, Rottapharm-Madausred yeast rice extract 200 mg (equivalent to 3 mg monacolins), policosanol 10 mg, berberine 500 mg, 0.2 mg folic acid, coenzyme Q10 2 mg, and astaxanthin 0.5 mg once daily | Dietary supplement | Nutraceutical combination |
| Standard of Carelow-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule | Other | Nutraceutical combination, Standard of Care + Placebo |
| Placeboplacebo | Other | Standard of Care + Placebo |
Primary outcome
Change from Baseline in LDL cholesterol at 3 months
Time frame: 3 months after treatment randomization
2 secondary outcomes
Change from Baseline in Circulating endothelial microparticles at 3 months
Time frame: 3 months after treatment randomization
Change from Baseline in C-reactive protein at 3 months
Time frame: 3 months after treatment randomization
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 22 Apr 2015.
- Background: PubMed 21177699McGorrian C, Yusuf S, Islam S, Jung H, Rangarajan S, Avezum A, Prabhakaran D, Almahmeed W, Rumboldt Z, Budaj A, Dans AL, Gerstein HC, Teo K, Anand SS; INTERHEART Investigators. Estimating modifiable coronary heart disease risk in multiple regions of the world: the INTERHEART Modifiable Risk Score. Eur Heart J. 2011 Mar;32(5):581-9. doi: 10.1093/eurheartj/ehq448. Epub 2010 Dec 22.
- Background: PubMed 11700160Pirro M, Bergeron J, Dagenais GR, Bernard PM, Cantin B, Despres JP, Lamarche B. Age and duration of follow-up as modulators of the risk for ischemic heart disease associated with high plasma C-reactive protein levels in men. Arch Intern Med. 2001 Nov 12;161(20):2474-80. doi: 10.1001/archinte.161.20.2474.
- Background: PubMed 16126969Gerli R, Sherer Y, Vaudo G, Schillaci G, Gilburd B, Giordano A, Bocci EB, Allegrucci R, Marchesi S, Mannarino E, Shoenfeld Y. Early atherosclerosis in rheumatoid arthritis: effects of smoking on thickness of the carotid artery intima media. Ann N Y Acad Sci. 2005 Jun;1051:281-90. doi: 10.1196/annals.1361.069.
- Background: PubMed 20191479Gerli R, Vaudo G, Bocci EB, Schillaci G, Alunno A, Luccioli F, Hijazi R, Mannarino E, Shoenfeld Y. Functional impairment of the arterial wall in primary Sjogren's syndrome: combined action of immunologic and inflammatory factors. Arthritis Care Res (Hoboken). 2010 May;62(5):712-8. doi: 10.1002/acr.20117.
- Background: PubMed 16159604St-Pierre AC, Cantin B, Bergeron J, Pirro M, Dagenais GR, Despres JP, Lamarche B. Inflammatory markers and long-term risk of ischemic heart disease in men A 13-year follow-up of the Quebec Cardiovascular Study. Atherosclerosis. 2005 Oct;182(2):315-21. doi: 10.1016/j.atherosclerosis.2005.02.009.
- Background: PubMed 11430324Ridker PM, Rifai N, Clearfield M, Downs JR, Weis SE, Miles JS, Gotto AM Jr; Air Force/Texas Coronary Atherosclerosis Prevention Study Investigators. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N Engl J Med. 2001 Jun 28;344(26):1959-65. doi: 10.1056/NEJM200106283442601.
- Background: PubMed 16946129Pirro M, Schillaci G, Paltriccia R, Bagaglia F, Menecali C, Mannarino MR, Capanni M, Velardi A, Mannarino E. Increased ratio of CD31+/CD42- microparticles to endothelial progenitors as a novel marker of atherosclerosis in hypercholesterolemia. Arterioscler Thromb Vasc Biol. 2006 Nov;26(11):2530-5. doi: 10.1161/01.ATV.0000243941.72375.15. Epub 2006 Aug 31.
- Background: PubMed 17720166Pirro M, Schillaci G, Bagaglia F, Menecali C, Paltriccia R, Mannarino MR, Capanni M, Velardi A, Mannarino E. Microparticles derived from endothelial progenitor cells in patients at different cardiovascular risk. Atherosclerosis. 2008 Apr;197(2):757-67. doi: 10.1016/j.atherosclerosis.2007.07.012. Epub 2007 Aug 27.
- Background: PubMed 19699071Affuso F, Ruvolo A, Micillo F, Sacca L, Fazio S. Effects of a nutraceutical combination (berberine, red yeast rice and policosanols) on lipid levels and endothelial function randomized, double-blind, placebo-controlled study. Nutr Metab Cardiovasc Dis. 2010 Nov;20(9):656-61. doi: 10.1016/j.numecd.2009.05.017. Epub 2009 Aug 20.
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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.
Matteo Pirro, MD, PhD principal investigator
University Of Perugia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nutraceutical Combination in people with Atherosclerosis and Inflammation, run by University Of Perugia.
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 2 inclusion and 13 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 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from Baseline in LDL cholesterol at 3 months (time frame: 3 months after treatment randomization). 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 NCT02422927, which also lists 9 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 22 Apr 2015.