Immune System, Innate Inflammatory Response
Conditions
Brief summary
In this study, the purpose was to describe and compare the modulator effects on the immune system of the routine ingestion of fresh vs. pasteurized yoghurt. A unicentral, prospective, randomized, double-blind, parallel group nutritional study for 8 weeks was carried out comparing the ingestion of 125 g (three times a day) of the products in healthy adults. A complete battery of in vitro tests on the activity of immune system, processes and phenomena was performed.
Interventions
OTHERPasteurised yoghurt
Pasteurised (heat treated) natural yoghurt containing \<15 CFU/g of Lactobacillus delbrueckii bulgacirus and \<15 CFU/g of Streptococcus thermophilus.
OTHERFresh yoghurt
containing ≥ 108 CFU/g of Lactobacillus delbrueckii bulgacirus and ≥ 108 CFU/g of Streptococcus thermophilus
OTHERSterilised yoghurt
Not containing viable bacteria
Sponsors
Danone Institute International
University of Seville
University of Valladolid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 20 and 70 years, both included. * Healthy or mildly ill subjects (without any current chronic pharmacotherapy). * Body mass index between 18.5 and 29.9 kg/m2, both included. * Subjects who usually follow a balanced diet that are not engaged in any therapeutic lifestyle change involving stringent dietary interventions such as weight-reducing diets. * Written informed consent to participate
Exclusion criteria
* Patients could not meet any the following criteria at the screening visit to be included in the study. * Subjects with diseases or disorders affecting the function of the immune system, such as auto-immune diseases, allergies, atopic conditions, hypersensitivity to any kind of stimulus, or immunosupression for any reason; even if they are not currently taken any pharmacotherapy. * Subjects with relevant functional or structural disorder affecting the gastrointestinal tract, such as malformations, angiodysplasias, active peptic ulcers or chronic inflammatory disease of the intestine; even if they are not in any specific pharmacotherapy at the time of recruitment; or who have underwent surgical procedures with permanent sequels (for example, gastroenterostomy). * Subjects with any infectious disease requiring antibiotherapy at the time of recruitment. * Subjects following any treatment modifying the immune response, such as immunosuppressants, corticosteroids, etc. * Subjects with celiac disease. * Subjects with chronic background weakening conditions, such as diabetes or neoplasms. * Subjects with history of renal lithiasis. * Subjects with deficient nutritional or hydrational status. * Subjects with relevant deviations in routine haematology or biochemistry parameters. * Subjects with current and documented alcohol abuse. * Subjects in whom the investigator expected insufficient collaboration or difficulties to follow the study procedures. * Subjects who regularly took any of the forbidden products specified in the appropriate section.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T-cells | Up to 6 weeks | T-cells measured as percentage of CD3 positive cells among the blood lymphocytes (defined by gating as CD45 bright and low cellular complexity or side scatter) |
| IFN-gamma induction | Up to 6 weeks | T-lymphocyte function: stimulation with PHA and measurement of Intracellular synthesis of IFN-γ in terms of percentage of IFN producing cells among the CD3 CD4 double positive (T helper cells) |
| IgG | Up to 6 weeks | serum IgG concentration measured in mg/dl |
Outcome results
None listed