Prehypertension Circulatory System Essential (primary) hypertension
Conditions
Interventions
Participants randomised to active or control group will be required during 4+4 weeks:
1. Active intervention: probiotics cheese 50g per day (probiotic Lactobacillus plantarum TENSIA d
Sponsors
BioCC OÜ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Wish to participate 2. Male and female subjects aged between 18 - ?65 years with a body weight between 50 and 100 kg and a body mass index between 18?29.9 kg/m2 3. High normal (130 - ?139 / 85 - ?89 mmHg) or hypertension grade 1 (140 -? 159/90 - ?99 mmHg) baseline blood pressure (BP) levels, as defined by ESH/ESC guidelines 4. Normal or not clinically significant deviations in safety laboratory values (clinical chemistry, blood count), WBC <8.8x 109/L, hs-CRP <5 mg/L; fasting glucose <6.0mmol/L, serum creatinine females <80 µmol/L, serum creatinine males <106 µmol/L, HbA1c < 6.5% 5. No use of any concomitant treatment which could influence the evaluation of the efficacy and tolerability of the investigational study product within one month prior to study start, including: 5.1. Supplementation with e.g. omega-3 fatty acids, omega-6 fatty acids, potassium, garlic, gingko biloba, polyphenols (e.g. quercetin), calcium, niacin, soy protein, green tea extract, oat fibre, plant sterols, psyllium seed husk or probiotics/probiotics 5.2. Intake of high amounts of walnuts 6. Signed informed consent
Exclusion criteria
Exclusion criteria: 1. History of any gastrointestinal disease 2. Use of any antimicrobial drug within last month 3. Use of any regular concomitant medication, including medical preparations including non-steroidal anti-inflammatory drugs and antioxidant vitamins 4. Food allergy 5. Diabetes and acute infection 6. Pregnancy or breastfeeding 7. SBP = 129 mmHg and/or DBP = 84 mmHg 7.1. Hypertension grade > 1 as defined by a SBP =160 mmHg and/or DBP =100 mmHg 7.2. History (e.g. stroke) or clinical signs of cardiovascular abnormalities, in particular cardiac arrhythmia and bradycardia (pulse rate <50 beats per minute)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Systolic) blood pressure, measured pre intervention, after 4 weeks and at the end of the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Reduction in DBP 2. Differences between verum and placebo in DBP values 3. Difference between verum and placebo in blood pressure values for the period 5 -8 weeks of product intake (by comparison of levels after 8 weeks with the levels after 4 weeks) 4. Samples are collected at run-in, baseline, after 4 weeks and at the end Measured pre intervention, after 4 weeks and at the end of the intervention | — |
Countries
Estonia
Outcome results
None listed