Elevated LDL cholesterol levels Nutritional, Metabolic, Endocrine Pure hypercholesterolaemia
Conditions
Interventions
The consumption of a probiotic yoghurt comprising Lactobacillus plantarum strain INDUCIA: daily dose of yoghurt 150 g, daily dose of probiotic: 8x10^9 colony forming units [CFU]) for 8 weeks vs consum
Sponsors
BioCC OÜ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A written informed consent 2. Aged between 18 - 65 years 3. No personally known health problems 4. Elevated levels of blood total cholesterol/cholesterol fractions: =3.0 mmol/l for LDL, =3.0 mmol/l for LDL/HDL ratio, =5.0 mmol/l for total cholesterol and =1.7 mmol/l for 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 and acute infection within the last 2 weeks prior to enrolment 3. 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 4. Intolerance to the investigational product/its ingredients 5. Any kind of concurrent disease which could influence the evaluation of the efficacy and the tolerability of the investigational study product 6. Any serious organ or systemic diseases 7. High blood pressure (e.g., >140/95 mmHg) 8. Eating disorder 9. Extensive exercise 10. Genetic hyperlipidemia 11. Drug or alcohol abuse 12. Active weight loss > 5 kg in prior 3 months 13. Participation in other studies within the last 30 days/during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. A significant reduction in blood LDL-cholesterol between probiotic and placebo group after 4 and 8 weeks of product intake 2. The first primary end point: reduction in blood LDL-cholesterol in probiotic group after 4 weeks of product intake 3. The second primary end point: reduction in blood LDL-cholesterol in probiotic group after 8 weeks of product intake Measured at baseline, at 4th week from the beginning of the trial, and at 8th week from the beginning of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In probiotic group maintenance or significant (p<0.05) reduction of: 1.1. Cholesterol/HDL-cholesterol ratio 1.2. LDL/HDL-cholesterol ratio, triglycerides 1.3. HLD-cholesterol 1.4. Adiponectin levels 8-isoprostanes 1.5. oxLDL-cholesterol 1.6. Leptin 1.7. IL-6 1.8. TNFa 1.9. HbA1c 1.10. OSI 2. Maintenance or significant (p<0.05) increase of: 2.1. HDL-cholesterol 2.2. Ca 2.3. iCa 2.4. Vitamin D Measured at baseline, at 4th week from the beginning of the trial, and at 8th week from the beginning of the trial | — |
Countries
Estonia
Outcome results
None listed