N/A
N=88
Effect of a Treatment With a Nutraceutical Combination on Sub-optimal LDL Cholesterol Levels
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT03739242 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Change in Blood LDL Cholesterol Level — -32.48; 2.54 mg/dL — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nutraceutical combination (Dietary_supplement); Placebo (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- A. Menarini Industrie Farmaceutiche Riunite S.r.l.
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Blood LDL Cholesterol Level |
-32.48; 2.54 | <0.0001 sig |
| SECONDARY Change in Total Blood Cholesterol Level |
-31.99; 7.17 | 0.0001 sig |
| SECONDARY Change in Blood HDL Cholesterol Level |
0.78; 1.11 | 0.9510 |
| SECONDARY Change in Blood Non-HDL Cholesterol Level |
-33.35; 3.65 | <0.0001 sig |
| SECONDARY Change in Blood Triglycerides Level |
-1.44; 17.62 | 0.1924 |
| SECONDARY Change in Blood Apolipoprotein B Level |
-14.79; 1.6 | <0.0001 sig |
| SECONDARY Change in Total Cholesterol/HDL Cholesterol Ratio |
-0.79; 0.06 | <0.0001 sig |
| SECONDARY Change in Total LDL Cholesterol/HDL Cholesterol Ratio |
-0.76; -0.01 | <0.0001 sig |
| SECONDARY Change in Pulse Volume (PV) Waveform (Endothelial Reactivity) |
-0.08; -0.03 | 0.4535 |
| SECONDARY Change in Glycemia |
-0.88; -1.57 | 0.5594 |
| SECONDARY Change in Aspartate Aminotransferase (AST) |
0.98; 0.86 | 0.9266 |
| SECONDARY Change in Alanine Aminotransferase (ALT) |
4.53; 2.93 | 0.2654 |
| SECONDARY Change in Gamma Glutamyl Transpeptidase (GGT) |
0.91; 3.07 | 0.2595 |
| SECONDARY Change in Serum Creatinine |
0; 0 | 0.8476 |
| SECONDARY Change in Serum Uric Acid |
-0.30; 0 | 0.1499 |
| SECONDARY Change in Creatine Phosphokinase (CPK) |
2.09; -7.00 | 0.7224 |
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.
Eligibility Criteria
Inclusion Criteria
-
Subjects must meet all of the following inclusion criteria:
- Age 30-75 years
- LDL-cholesterol = 115 -190 mg/dL
- Triglycerides 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
Data sourced from ClinicalTrials.gov (NCT03739242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.