Effect of probiotic cheese on blood indices and intestinal microflora of healthy volunteers and elderly individuals

Effect of probiotic cheese on blood indices and intestinal microflora of healthy adult and healthy elderly volunteers: a randomised, double-blind, dietary cross-over intervention study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15061552

Enrollment

210

Registered

2009-10-02

Start date

2009-10-05

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Blood indices and intestinal microflora Digestive System Improving intestinal flora

Interventions

Probiotic cheese consumption versus regular cheese consumption. Group I: Volunteers are randomly allocated to receive either: 1. 50 g probiotic cheese or control cheese once a day for 3 weeks. Prob

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Wish to participate in the study 2. Aged 18 years and over (group I), aged over 60 (Group II), either sex 3. Healthy (i.e. no known health problems and no medical conditions that require drug therapy) 4. Signed informed consent

Exclusion criteria

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 4. Food allergy 5. Pregnancy or breastfeeding (Group I)

Design outcomes

Primary

Measure	Time frame
Group I: Blood, urine and faecal samples are collected at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment. The survival of the probiotic strain in gastrointestinal tract (GIT) and its effect on intestinal microflora and clinical blood indices of healthy volunteers is measured. Group II: At the recruitment and 6 hours after cheese consumption the arterial elasticity will be assessed. After 6 hours another blood sample is collected and after 4 days the whole procedure is repeated.	—

Measure

Time frame

Group I: Blood, urine and faecal samples are collected at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment. The survival of the probiotic strain in gastrointestinal tract (GIT) and its effect on intestinal microflora and clinical blood indices of healthy volunteers is measured. Group II: At the recruitment and 6 hours after cheese consumption the arterial elasticity will be assessed. After 6 hours another blood sample is collected and after 4 days the whole procedure is repeated.

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Secondary

Measure	Time frame
Group I: 1. The assessment of the health indices of study participants (body mass index, blood pressure), measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment 2. The self-reported questionnaire is applied containing questions on welfare, nutritional habits, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), measured once a week during the trial 3. To determine haematological indices (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, albumin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), triglyceride and high-sensitive C-reactive protein (hs-CRP), interleukin 6 (IL-6), will be measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out and after a 3-week placebo treatment 5. Biogenic amines from urine samples will be measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment 6. Faecal samples will be analysed for the changes in the counts of lactic acid bacteria Group II: 1. The assessment of the health indices of study participants (body mass index, blood pressure), measured at recruitment 2. Faecal samples are collected at recruitment and will be analysed for the changes in the counts of lactic acid bacteria 3. Haematological indices will be measured at recruitment and 6 hours later (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, albumin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), triglyceride and high-sensitive C-reactive protein (hs-CRP), interleukin 6 (IL-6), IgM, IgA, IgG, oxidative stress markers: oxLDL, several cytockines and growth factors (IL1alfa, IL1beta, IL2, IL4, IL6, IL8, IL10, VEGF, EDG, ITF-gamma, TNFalfa, MCP-1) 4. 8-	—

Measure

Time frame

Group I: 1. The assessment of the health indices of study participants (body mass index, blood pressure), measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment 2. The self-reported questionnaire is applied containing questions on welfare, nutritional habits, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), measured once a week during the trial 3. To determine haematological indices (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, albumin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), triglyceride and high-sensitive C-reactive protein (hs-CRP), interleukin 6 (IL-6), will be measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out and after a 3-week placebo treatment 5. Biogenic amines from urine samples will be measured at the recruitment, after 3 weeks of probiotic treatment, after a 2-week wash-out period and after a 3-week placebo treatment 6. Faecal samples will be analysed for the changes in the counts of lactic acid bacteria Group II: 1. The assessment of the health indices of study participants (body mass index, blood pressure), measured at recruitment 2. Faecal samples are collected at recruitment and will be analysed for the changes in the counts of lactic acid bacteria 3. Haematological indices will be measured at recruitment and 6 hours later (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, albumin, total cholesterol (TC), low-density lipoprotein cholesterol (LDL), high-density lipoprotein cholesterol (HDL), triglyceride and high-sensitive C-reactive protein (hs-CRP), interleukin 6 (IL-6), IgM, IgA, IgG, oxidative stress markers: oxLDL, several cytockines and growth factors (IL1alfa, IL1beta, IL2, IL4, IL6, IL8, IL10, VEGF, EDG, ITF-gamma, TNFalfa, MCP-1) 4. 8-

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Countries

Estonia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 6, 2026