Effect of the probiotic cheese on high-normal blood pressure

Effect of the probiotic Südamejuust (heart friendly cheese) comprising Lactobacillus plantarum TENSIA DSM 21380 on subjects with high-normal blood pressure: a randomized blinded controlled parallel three-arm study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29040130

Enrollment

120

Registered

2011-08-24

Start date

2011-09-19

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension Circulatory System Essential (primary) hypertension

Interventions

Participants randomised to active, placebo or control group will receive the intervention for 3 weeks: 1. Active intervention: probiotics cheese 50 g per day (probiotic Lactobacillus p

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

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Countries

Estonia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026