Effect of kefir containing probiotic Lactobacillus fermentum ME-3 on healthy volunteers

INTERVENTION: Blocked randomization lists were produced by the statistician and held centrally. The consumption of a probiotic kefir comprising Lactobacillus fermentum strain ME‐3: daily dose of kefir 200 ml, daily dose of probiotic: 8x10^9 colony forming units for 8 weeks vs consumption of control kefir 200 ml. The participants provided blood samples four times: at selection, at the start and after 4 and 8 weeks; stool and urine samples were collected three times: at the start and after 4 and 8 weeks of intervention. CONDITION: Elevated values of blood triglycerides, blood cholesterol and its fractions ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: Cardiovascular health:; 1. Significant decrease of LDL‐cholesterol ; 2. Significant decrease of triglycerides; ; Protection against oxidative damage:; 1. Significant decrease of oxidized LDL ; 2. Significant decrease of urinary isoprostanes SECONDARY OUTCOME: Cardiovascular health:; In probiotic group maintenance or significant reduction (p<0.05) of: ; 1. HDL‐cholesterol; 2. Homocysteine; 3. ApoB/apoA1; 4. hs‐CRP; 5. Leptin ; 6. Adiponectin; 7. Blood pressure; ; Protection against oxidative damage:; In probiotic group maintenance or significant reduction (p<0.05) of: ; 1. Oxidative stress index (OSI) ; 2. Glutathione redox status (GSSG/GSH); 3. MPO; 4. IL‐6; 5. TNF‐alpha; ; Temporal colonization of GI tract with L. fermentum ME‐3 detected in faecal samples.; ; Measured at baseline, at the 4th week and the 8th week from the beginning of the trial. INCLUSION CRITERIA: 1. A written informed consent 2. Age between 35 and 65 years 3. No known health problems 4. Elevated levels of blood total cholesterol/cholesterol fractions: >3.4 mmol/l for LDL, >3.0 mmol/l for the LDL/HDL ratio, >5.2 mmol/l for the total cholesterol and >1.7mmol/l for the level of triglycerides 5. No use of any concomitant treatment which could influence the evaluation of the efficacy and the tolerability of the investigational study product, including lipid‐lowering drugs (e.g. statins, bile acid sequestrates, cholesterol absorption inhibitors, nicotinic acid), supplementation with e.g. omega‐3 fatty acids, calcium, oat fiber, niacin, green tea extract, plant sterols, soy protein, psyllium seed husk or probiotics/prebiotics within the preceding 2 months 6. Willingness to maintain a stable diet and physical activity level 7. Normal or not clinically pronounced safety lab values (clinical chemistry, blood count) except for lipids