Elevated values of blood lipids, oxidative stress, inflammation and blood glucose related indices. Nutritional, Metabolic, Endocrine
Conditions
Interventions
The consumption of a food supplement Reg?Activ Cholesterol: daily dose two capsules for 4 and 8 weeks vs consumption of control capsules
Sponsors
GIE Eurasanté (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A written informed consent 2. Aged between 40 - 70 years 3. No known health problems 4. Total cholesterol higher than 5.3 mmol/L or LDL-chol higher than 3.0mmol/L or triglycerides higher than 1.7 mmol/L or total cholesterol/HDL higher than 4 or LDL/HDL higher than 3 or glycated Hb higher than 5.7% or hsCRP higher than 1,0 mg/L or homocysteine higher than 11 micromol/L 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, vitamins, soy protein, psyllium seed husk or probiotics/prebiotics within the preceding at least 3 weeks 6. Willingness to maintain a stable diet and physical activity level
Exclusion criteria
Exclusion criteria: 1. Pregnancy and breastfeeding 2. History of gastrointestinal disease 3. Food allergy 4. Diabetes 5. Acute infection within the last 3 weeks prior to enrolment 6. Use of any antimicrobial agents within the preceding 2 months 7. Use of any regular concomitant medication including any non-steroidal anti-inflammatory drugs and antioxidant products 3 weeks 8. Intolerance to the investigational product / its ingredients 9. Any kind of concurrent disease which could influence the evaluation of the efficacy 10. Tolerability of the investigational study product 11. Any serious organ or systemic diseases 12. Eating disorder 13. Extensive exercise 14. Genetic hyperlipidemia 15. Drug or alcohol abuse 16. Active weight loss > 5 kg in prior 3 months participation in other studies within the last 30 days / during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. LDL cholesterol 2. Triglycerides 3. Glycated hemoglobin 4. Oxidized LDL 5. Isoprostanes Measured at baseline, at 4th week from the beginning of the trial, 8th week from the beginning of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. HsCRP 2. Homocysteine 3. IL-6 4. TG/HDL ratio 5. Oxidative stress index 6. Proinflammatory cytokines 7. Adiponectin 8. Antiinflammatory cytokines Measured at baseline, at 4th week from the beginning of the trial, 8th week from the beginning of the trial. | — |
Countries
Estonia
Outcome results
None listed