Effect of the probiotic cheese on high-normal blood pressure

Phase 2

Completed

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

• Registration Number: ISRCTN29040130
• Lead Sponsor: BioCC OÜ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-24
• Study Completion: 2011-11-07
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Wish to participate
2. Aged 18 years and over
3. Baseline blood pressure levels high-normal according to European Society of Hypertension (ESH)/European Society of Cardiology (ESC) Guidelines for the Management of Arterial Hypertension (2007): systolic blood pressure (SBP) 130-139 mmHg, diastolic blood pressure (DBP) 85-89 mmHg, white blood cell (WBC) < 8.8x109 /L, high sensitivity C-reactive protein (hs-CRP) < 5 mg/L, glucose <6.0 mmol/L, serum creatinine F < 80 µmol/L, M: <106 µmol/L.
4. Signed informed consent

Exclusion Criteria

1. History of any gastrointestinal disease
2. Use of any antimicrobial drug within the 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Decrease in systolic and/or diastolic blood pressure measured pre intervention, at the end of the intervention and also 1 week post intervention.

Secondary Outcome Measures

Name	Time	Method
<br> The following outcomes will be measured pre intervention, at the end of the intervention and also 1 week post intervention.<br> 1. Body mass index (BMI)<br> 2. Changes in inflammatory markers (WBC, hs-CRP)<br> 3. Changes in lipidogram [total cholesterol and/or low density lipoprotein (LDL)-cholesterol and/or triglycerides]<br> 4. Changes in fecal microflora<br> 5. Persistence of ingested probiotic strain for 1 week<br> 6. Blood, fecal and urine samples are collected at run-in, baseline and end of the study<br>