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Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels (NATCOL)

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ClinicalTrials.gov Identifier: NCT03739242
Recruitment Status : Completed
First Posted : November 12, 2018
Results First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
A. Menarini Industrie Farmaceutiche Riunite S.r.l.

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: Nutraceutical combination Other: Placebo Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 12, 2017
Actual Primary Completion Date : August 29, 2018
Actual Study Completion Date : August 29, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutraceutical combination
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.
Dietary Supplement: Nutraceutical combination
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)

Placebo Comparator: Placebo
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.
Other: Placebo
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)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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 ]
    Mean change in total blood LDL cholesterol level from randomization (day 0) to V4 (week 8)

  2. 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 ]
    Mean change in blood HDL cholesterol level from randomization (day 0) to V4 (week 8)

  3. 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 ]
    Mean change in blood non-HDL cholesterol level from randomization (day 0) to V4 (week 8)

  4. Change in Blood Triglycerides Level [ Time Frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment ]
    Mean change in blood triglycerides level from randomization (day 0) to V4 (week 8)

  5. 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 ]
    Mean change in blood apolipoprotein B level from randomization (day 0) to V4 (week 8)

  6. 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 ]
    Mean change in total cholesterol/HDL cholesterol ratio from randomization (day 0) to V4 (week 8)

  7. 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 ]
    Mean change in LDL/HDL cholesterol ratio from randomization (day 0) to V4 (week 8)

  8. 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 ]

    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).


  9. Change in Glycemia [ Time Frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment ]
    Mean change in Glycemia from randomization (day 0) to V4 (week 8)

  10. Change in Aspartate Aminotransferase (AST) [ Time Frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment ]
    Mean change in aspartate aminotransferase from randomization (day 0) to V4 (week 8)

  11. Change in Alanine Aminotransferase (ALT) [ Time Frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment ]
    Mean change in aspartate aminotransferase from randomization (day 0) to V4 (week 8)

  12. 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 ]
    Mean change gamma glutamyl transpeptidase (GGT) from randomization (day 0) to V4 (week 8)

  13. Change in Serum Creatinine [ Time Frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment ]
    Mean change in Serum Creatinine values from randomization (day 0) to V4 (week 8)

  14. Change in Serum Uric Acid [ Time Frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment ]
    Mean change in Serum uric acid values from randomization (day 0) to V4 (week 8)

  15. Change in Creatine Phosphokinase (CPK) [ Time Frame: From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment ]
    Mean change in creatine phosphokinase (CPK) from randomization (day 0) to V4 (week 8)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-

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

Exclusion Criteria:

-

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739242


Locations
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Italy
Policlinico S.Orsola - Malpighi Medicina Interna Borghi
Bologna, Italy, 40138
Sponsors and Collaborators
A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Investigators
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Principal Investigator: Claudio Borghi, Professor Policlinico S.Orsola - Malpighi Medicina Interna Borghi
  Study Documents (Full-Text)

Documents provided by A. Menarini Industrie Farmaceutiche Riunite S.r.l.:
Study Protocol  [PDF] April 16, 2018
Statistical Analysis Plan  [PDF] December 17, 2018


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Responsible Party: A. Menarini Industrie Farmaceutiche Riunite S.r.l.
ClinicalTrials.gov Identifier: NCT03739242     History of Changes
Other Study ID Numbers: MEIF/MOF-Col/001
First Posted: November 12, 2018    Key Record Dates
Results First Posted: October 14, 2019
Last Update Posted: October 14, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by A. Menarini Industrie Farmaceutiche Riunite S.r.l.:
Lipids
Cholesterol
Triglycerides
Dyslipidemia
Low density lipoprotein cholesterol
Dietary Fats
Hyperlipidemias
Dietary Supplements
Food Supplements
Nutraceuticals
Nutriceuticals
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases