Prehypertension Circulatory System
Conditions
Interventions
Participants are 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 eight weeks. The cap
Sponsors
BioCC LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Age over 30 years 3. Willingness to maintain a stable diet and physical activity level 4. Normal or not clinically relevant deviations in safety laboratory values 5. High normal or grade 1 systolic/diastolic blood pressure (=159/99 mm Hg) with up to medium added risks in coronary-heart diseases 6. No use of any concomitant treatment (including blood pressure lowering drugs e.g. ACE-inhibitors, blockers of beta adrenergic receptors, calcium channel blockers and diuretics) and lipid lowering drugs (e.g. statins, bile acid sequestrates, cholesterol absorption inhibitors, nicotinic acid)
Exclusion criteria
Exclusion criteria: 1. Pregnancy and breastfeeding 2. (Food) allergy 3. Intolerance to the investigational product / its ingredients 4. Diabetes 5. Eating disorder 6. Active weight loss > 5 kg in prior 3 months 7. Extensive exercise (daily trainings of professional athletes) 8. Drug or alcohol abuse 9. Participation in other studies within the last 30 days / during the study 10. Any history of gastrointestinal diseases 11. Acute infection within the last 2 weeks prior to baseline 12. Use of any antimicrobial agents within the preceding 1 month 13. Donor within the last 1,5 months prior to start of the study (i.e. baseline visit) 14. Use of any pre-, probiotic or food supplement within the last 2 weeks prior to start of the study 15. Chronic inflammatory diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in systolic blood pressure (SBP) measured with a mercury sphygmomanometer at 8 weeks from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in SBP measured with a mercury sphygmomanometer at 4 weeks from baseline level and at 8 weeks from level at 4 weeks 2. Changes in diastolic blood pressure measured with a mercury sphygmomanometer at 8 weeks from baseline level, at 4 weeks from baseline level and at 8 weeks from level at 4 weeks Changes at 8 weeks from baseline and at 4 weeks from baseline in the following outcome measures: 3. Oxidative stress indices and renin-angiotensin-aldosterone system (RAAS) indices measured from blood and urine samples using different ELISA based assays 4. Short chain fatty acids (SCFA) measured from stool samples using High Pressure Liquid Chromatography (HPLC) 5. Gut microflora indices (lactoflora, anaerobes etc) measured from stool samples using molecular approaches and specific primers | — |
Countries
Estonia
Outcome results
None listed