Elevated LDL cholesterol levels Circulatory System
Conditions
Interventions
Participants are randomly allocated to one of two groups. Randomisation is prepared by a study statistician using statistical analysis software and participants are randomly allocated to one of the tr
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. 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) 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) 8. LDL-cholesterol values =3.0 mmol/l– 5.3 mmol/l
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 |
|---|---|
| Blood oxLDL-cholesterol level measured using blood tests (ELISA) at baseline and weeks 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ox-LDL values measured using blood tests (ELISA) at baseline and weeks 4 2. Total cholesterol, LDL-cholesterol, non-HDL-cholesterol measured by standard laboratory methods in the United Laboratories of Tartu University Hospital (Estonia) from fasting blood serum at baseline, weeks 4 and weeks 8 3. Blood oxidative stress indices measured from blood serum by ELISA at baseline, weeks 4 and weeks 8 | — |
Countries
Estonia
Outcome results
None listed