Condition category
Circulatory System
Date applied
29/10/2012
Date assigned
15/11/2012
Last edited
12/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Having high blood pressure (hypertension) increases the risk of serious problems such as heart attacks and strokes. Reducing blood pressure reduces the risk of heart disease and stroke. Lifestyle and diet changes are helpful for people whose blood pressure is higher than normal but not high enough to require drug treatment. The aim of this study is to assess the effect of a probiotic Edam-type cheese on blood pressure reduction.

Who can participate?
Generally healthy people aged 18 and over with elevated blood pressure, who do not take medication

What does the study involve?
Participants are randomly allocated to eat 50 g per day of either probiotic cheese or normal cheese. The study duration is 4 weeks, and participants are asked to assess their well-being and gastrointestinal (digestive) effects, and also to provide blood, urine and fecal samples to test the effect of the probiotic.

What are the possible benefits and risks of participating?
Participants receive an assessment of their health status and if necessary, a free consultation
with a nutritionist and/or a specialist. The study causes minimal inconvenience to participants. As blood samples are taken by an experienced nurse, the procedure is safe. However, as with any blood test there may be bruising and discomfort at the site of the blood test. The amounts of blood we are taking are small enough that they should not make you feel fatigue or cause anemia.

Where is the study run from?
The Centre for Clinical and Physiological Research of the Bio-Competence Centre of Healthy Dairy Products LLC in Tartu, Estonia

When is the study starting and how long is it expected to run for?
March to December 2012

Who is funding the study?
EU Structural Funds

Who is the main contact?
Dr Pirje Hütt
pirje.hutt@ut.ee

Trial website

Contact information

Type

Scientific

Primary contact

Dr Epp Songisepp

ORCID ID

Contact details

Kreutzwaldi 1
Tartu
51014
Estonia
-
esongisepp@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

202M-25

Study information

Scientific title

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

Acronym

Study hypothesis

The consumption of probiotic cheese helps to maintain the normal blood pressure by reducing high-normal systolic and/or diastolic blood pressure.

Ethics approval

Human Research Ethics Review Committee, University of Tartu, 14/03/2011, ref: 202M-25

Study design

Randomized double-blind controlled parallel-designed two-armed intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prehypertension

Intervention

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 daily dose: 10^10 colony forming units [CFU])
2. Control: 50 g control cheese without probiotic additive

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

01/03/2012

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150 (75 subjects in each arm)

Participant 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)

Recruitment start date

01/03/2012

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Estonia

Trial participating centre

Kreutzwaldi 1
Tartu
51014
Estonia

Sponsor information

Organisation

Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)

Sponsor details

Kreutzwaldi 1
Tartu
51014
Estonia
-
merlera@ut.ee

Sponsor type

Research organisation

Website

https://www.tptak.ee

Funders

Funder type

Government

Funder name

European Union (EU) Structural Funds, ref: EU30002

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/09/2016: Plain English summary added.