Effect of the probiotic cheese on high-normal blood pressure

Not Applicable

Completed

• Conditions: Prehypertension; Circulatory System; Essential (primary) hypertension

• Registration Number: ISRCTN29105501
• Lead Sponsor: BioCC OÜ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-15
• Study Completion: 2012-12-31
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
(Systolic) blood pressure, measured pre intervention, after 4 weeks and at the end of the intervention

Secondary Outcome Measures

Name	Time	Method
<br> 1. Reduction in DBP<br> 2. Differences between verum and placebo in DBP values<br> 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)<br> 4. Samples are collected at run-in, baseline, after 4 weeks and at the end<br><br> Measured pre intervention, after 4 weeks and at the end of the intervention<br>