Elevated cholesterol levels Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants were randomly allocated to either the intervention group or the placebo group applying a 1:1 allocation ratio.
Group 1 (verum): Participants take one capsule daily for twelve weeks. The c
Sponsors
BioCC LCC (formerly Bio-Competence Centre of Healthy Dairy Products (Estonia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Aged between 30 and 65 years old 3. Willingness to maintain a stable diet and physical activity level 4. Willingness to cease using probiotic products and supplements (except vitamin D) during the study period 5. Normal or not clinically relevant deviations in safety laboratory values 6. One of the following outcomes at the screening visit: LDL-cholesterol value >3.4 mmol/L; LDL-cholesterol/HDL-cholesterol >3.5 mmol/L or total cholesterol/HDL between 3.5 and 4.5 mmol/L
Exclusion criteria
Exclusion criteria: 1. Using blood pressure and/or cholesterol lowering drugs/supplements within the last 3 months prior to start of the study (i.e. baseline visit) 2. Diabetes 3. Acute or chronic inflammatory disease 4. Endocrinological disease 5. (Food) allergy 6. Using antibiotic within the last 4 weeks prior to start of the study (i.e. baseline visit) 7. Using NSAIDs regularly 8. Pregnancy and breastfeeding 9. Donor within the last 3 months prior to start of the study (i.e. baseline visit) 10. Smoking 11. Use of any pre-, probiotic or food supplement within the last 2 weeks prior to start of the study 12. Intolerance to the investigational product/its ingredients 13. Acute infection within the last 2 weeks prior to baseline 14. Eating disorder 15. Extensive exercise (daily training of professional athletes) 16. Drug or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. LDL-cholesterol level in blood serum at baseline, and weeks 8, 12 and 14 2. Total-cholesterol level in blood serum at baseline, and weeks 8, 12 and 14 3. Oxidative stress indices measured from blood and urine samples using different ELISA-based assays at baseline, and weeks 8 and 12 4. Gut microflora indices (lactoflora, anaerobes etc) measured from stool samples using molecular approaches and specific primers at baseline, and weeks 8, 12 and 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Metabolic syndrome indices measured from blood samples using different ELISA-based assays at baseline, and weeks 8 and 12 2. Short-chain fatty acids (SCFA) measured from stool and urine samples using High-Pressure Liquid Chromatography (HPLC) at baseline, and weeks 8, 12 and 14 3. Bile acids concentration measured from stool and urine samples High-Pressure Liquid Chromatography (HPLC) at baseline, and weeks 8, 12 and 14 | — |
Countries
Estonia
Outcome results
None listed