None listed
Conditions
Brief summary
This trial aims to evaluate the cholesterol-lowering effect of a nutraceutical flavonoid-rich extract of bergamot fruit and polyphenol-rich olive fruit in combination with phytosterols and vitamin K2, named BruMeCholTM, in the serum of subjects with mild hypercholesterolemia . The study will be conducted as a randomized, double-blind, placebo-controlled, parallel group clinical trial for a period of 12 weeks at the Cardiology Unit of the IRCCS INRCA of Ancona, Italy. A total of 125 subjects (age >40 years) with mild hypercholesterolemia levels (total cholesterol levels between 200 and 250 mg/dl) will be recruited for the study. Participants will take 1 capsule of dietary supplement or placebo two times a day, 15 minutes before the main meal for 12 weeks. Change in serum total cholesterol levels will be evaluated to verify the efficacy of the dietary supplement BrumecholTM in reducing blood total cholestrol levels.
Interventions
1 capsule of dietary supplement named BruMeCholTM twice/day for 12 weeks. The capsule of dietary supplement contains a mixture of nutraceutical flavonoid-rich extract of bergamot fruit (100 mg) and polyphenol-rich olive fruit (20 mg) in combination with phytosterols (400 mg) and vitamin K2 (52 mcg). In order to check the compliance, subjects will be asked to bring trial treatment kits (with or without any remaining capsules) with them to each visit.
Sponsors
IRCCS INRCA
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- blood total cholesterol levels between 200 and 250 mg/dL - no history of clinically relevant cardiovascular events - signed informed consent form
Exclusion criteria
- current therapy with statins or food supplements with lipid-reducing effect - total cholesterol > 250 or < 200 mg/dl; - therapy with anticoagulants; - hypothyroidism, orhyperthyroidism - insulin-dependent diabetes or diabetes associated with macrovascular complications) - intestinal malabsorption; - acute illnesses - neoplastic disease or < 1-year life expectancy; - statin non-related liver disease - severe chronic renal failure - allergy/intolerance to one or more components of dietary supplement or placebo - participation in another clinical trial of intervention in the previous three months. - presence of cognitive disorders and other impediments that do not guarantee the correct adherence to the study treatments; - current or presumed pregnancy and pregnancy planning; - incapacity, impossibility or unavailability to sign the written consent.
Outcome results
None listed