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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- Change in Blood LDL Cholesterol Level
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Nutraceutical combination (Dietary Supplement)
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.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
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 Outcomes
- Change in Total LDL Cholesterol/HDL Cholesterol Ratio(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Blood Triglycerides Level(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Blood Apolipoprotein B Level(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Blood HDL Cholesterol Level(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Blood Non-HDL Cholesterol Level(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Serum Creatinine(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Total Cholesterol/HDL Cholesterol Ratio(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Total Blood Cholesterol Level(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Serum Uric Acid(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Creatine Phosphokinase (CPK)(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)(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Glycemia(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Aspartate Aminotransferase (AST)(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Alanine Aminotransferase (ALT)(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)
- Change in Gamma Glutamyl Transpeptidase (GGT)(From randomization (day 0) to V4 (week 8) for a total of 56 +/- 3 days of treatment)