Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia
Brief summary
The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels. The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycolysated hemoglobin
Interventions
OTHERFood supplement
Sponsors
Meir Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\) Patients on maximal tolerated dose of conventional statins treated for at least eight weeks on simvastatin 40, pravastatin 40, atorvastatin 40-80 or rosuvastatin 20-40 mg, who failed to achieve target values of LDL-cholesterol according to the European Socety Cardiology guidelines 2012.
Exclusion criteria
1. Patients on chronic antibiotic treatment 2. Patients with immune disorders 3. Patients who are not receiving maximal dose of statin therapy or receive combination of statins for dyslipidemia. 4. Patients who experienced myocardial infarction within less than two months. 5. Patients who consume probiotics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-Cholesterol levels. | 8 weeks | The primary objective is to examine whether probiotics given to hypercholesterolemic patients treated with statins, would further decrease LDL-Cholesterol levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin A1C | 8 weeks | The secondary objective is to examine whether adding of probiotics to statins would decrease fasting glucose levels and glycosylated hemoglobin |
Countries
Israel
Contacts
Primary ContactMorris Mosseri, MD
Backup ContactTatiana Berlin, MD
Outcome results
None listed