Effect of probiotic yoghurt on blood indices and intestinal microflora of healthy volunteers

Completed

Conditions: Intestinal microflora, blood pressure and immunological parameters of healthy adults
Not Applicable

Registration Number: ISRCTN68198472

Lead Sponsor: Bio-Competence Centre of Healthy Dairy Products Ltd. (Estonia)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

1. Wish to participate in the study
2. Both males and females, aged 18-65 years
3. Healthy (i.e. no known health problems and no medical conditions that require drug therapy)
4. Signed informed consent

Exclusion Criteria

1. History of any gastrointestinal disease
2. Use of any antimicrobial agent within the preceding month
3. Use of any regular concomitant medication including non-steroidal anti-inflammatory drugs and antioxidant vitamins
4. Pregnancy or breastfeeding
5. Food allergy
6. Diabetes and acute infections

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following will be measured at recruitment, after 3-week intervention, after 2-week washout and at the end of another 3-week intervention: <br>1. Clinical blood indices<br>2. Intestinal microflora

Secondary Outcome Measures

Name	Time	Method
The following will be measured at recruitment, after 3-week intervention, after 2-week washout and at the end of the trial i.e. at the end of another 3-week intervention:<br>1. The self-reported questionnaire containing questions on welfare, nutritional habits, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency) <br>2. Haematological indices, plasma glucose, total cholesterol (TC), high density lipoprotein (HDL) and low density lipoprotein (LDL) cholesterol, triglyceride and high sensitivity C-reactive protein (hsCRP), Interleukin-6 (IL-6), immunoglobulin levels <br>3. The content of biogenic amines and polyamines in urine <br>4. Reverse transcription polymerase chain reaction (RT-PCR) from fecal samples for monitoring the changes in the counts of lactoflora, L. planatrum and survival of the administered strains <br>5. Denaturing gradient gel electrophoresis (DGGE) used to monitor changes in total fecal microflora after yoghurt consumption