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Effect of probiotic yoghurt (L. plantarum strain TENSIA) on healthy volunteers

Effect of probiotic yoghurt comprising L. plantarum strain TENSIA on blood indices and intestinal microflora of healthy volunteers: A randomised controlled crossover trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN31663396
Enrollment
100
Registered
2011-06-21
Start date
2011-02-07
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

Blood indices, intestinal microflora Digestive System Intestinal microflora

Interventions

The consumption once a day 150 g of probiotic yoghurt versus regular yoghurt for 3 weeks. Probiotic yoghurt containing either Lactobacillus plantarum strain TENSIA (10^9 colony forming units [CFU]/g).

Sponsors

BioCC OÜ
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Wish to participate in the study 2. Aged 18 years and over, 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

Design outcomes

Primary

MeasureTime frame
1. The health indices of study participants (height, weight, body mass index, blood pressure) assessed at the recruitment, after 3 weeks of probiotic treatment, after washout and after 3-week placebo treatment 2. The self-reported questionnaire containing questions on welfare, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency), measured once a week during the trial 3. Haematological indices (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, albumin, total cholesterol, low density lipoprotein (LDL)-cholesterol, high density lipoprotein (HDL)-cholesterol, triglycerides, high sensitivity C reactive protein (hs-CRP) and interlukin (IL)-6 measured at the recruitment, after 3 weeks of probiotic treatment, after washout and after 3-week placebo treatment

Secondary

MeasureTime frame
Circulation of polyamines in host, oxidised low density lipoprotein (oxLDL), 8-isoprostanes, adiponectine, leptin, cytokines and growth factors (IL1 alfa, IL1beta, IL2, IL4, IL6, IL8, IL10, VEGF, EDG, ITFgamma, TNFalfa, MCP-1), osteoprotegerin

Countries

Estonia

Outcome results

None listed

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