Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

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.
    

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).
    

Intervention name(s): Nutraceutical combination; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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); 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)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Lipids; Cholesterol; Triglycerides; Dyslipidemia; Low density lipoprotein cholesterol; Dietary Fats; Hyperlipidemias; Dietary Supplements; Food Supplements; Nutraceuticals; Nutriceuticals