Elevated values of blood triglycerides, blood cholesterol and its fractions Nutritional, Metabolic, Endocrine
Conditions
Interventions
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, dai
stool and urine samples were collected three times: at the start and after 4 and 8 weeks of intervention.
Sponsors
Tere AS (Estonia)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Pregnancy and breastfeeding 2. A history of gastrointestinal disease, food allergy, diabetes 3. Acute infection within the last 2 weeks prior to enrolment 4. Use of any antimicrobial agents within the preceding 2 months or use of any regular concomitant medication including any non-steroidal anti-inflammatory drugs and antioxidant products 2 weeks 5. Intolerance to the investigational product / its ingredients 6. Any kind of concurrent disease which could influence the evaluation of the efficacy and the tolerability of the investigational study product 7. Any serious organ or systemic diseases 8. High blood pressure (e.g. >140/95 mm Hg) 9. Eating disorder 10. Extensive exercise 11. Genetic hyperlipidemia 12. Drug or alcohol abuse 13. Active weight loss > 5 kg in prior 3 months 14. Participation in other studies within the last 30 days / during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Estonia
Outcome results
None listed